Text

Arco Environmental Remediation, LLC; Notification Action Letter Dtd April 3, 2019
	ML19100A408
Person / Time
Site:	07003078
Issue date:	04/03/2019
From:	Kezos C; ARCO Environmental Remediation, Atlantic Richfield Co
To:	; Division of Nuclear Materials Safety I
Shared Package
ML19100A407	List: ML19100A408; ML19108A279;
References
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	Download: ML19100A408 (39)
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Atlantic Richfield Company April 3, 2019 U.S. Nuclear Regulatory Commission, Region 1 ATIN: Director of Nuclear Materials Safety 2100 Renaissance Ave., Suite 100 King of Prussia, PA 19406 RE:

License #SNM 1993 Condition 12 Report - 2018 Cynthia D. Kezos Liability Business Manager 4 Centerpointe Drive, Suite 200 La Palma, CA 90623 Office:

657-529-4520 Fax:

714-670-5195 Mobile:

714-264-3785 Cindy.kezos@bp.com I am writing you on behalf of ARCO Environmental Remediation LLC (ARCO).

Enclosed please find the report entitled "Radioisotope Powered Cardiac Pacemaker Program Technical Memorandum Report XLVIII on the Status of the Clinical Studies of the Nuclear Pacemaker Model NU-5 from the ARCO Medical Products Company."

This report satisfies Condition 12 of ARCO's Special Nuclear Materials License.

If you have any questions or need additional information, please contact me.

Si~e~(~~0 5 Cynthia D. Kezos Liability Business Manager Remediation Management Services Company An affiliate of Atlantic Richfield Company Enclosure Cc:

K. Paul Steinmeyer, Radiation Safety Associates 0 A BP Affiliated Company

RADIOISOTOPE POWERED CARDIAC PACEMAKER PROGRAM TECHNICAL MEMORANDUM REPORT LI ON THE STATUS OF THE CLINICAL STUDIES OF THE NUCLEAR PACEMAKER MODEL NU-5 FROM THE ARCO MEDICAL PRODUCTS COMPANY, A SUBSIDARY OF ATLANTIC RICHFIELD February 12, 2019 Prepared By:

A-,l I fi~

/ 11./; ~.:- ';[.l 4-._"::-J',I --

K Paul Steinmeyer, RRPT Radiation Safety Officer Radiation Safety Associates, Inc. for Atlantic Richfield Company

SECTION II III IV V

TABLE!

TABLE II ATTACHMENT A ATTACHMENT B ATTACHMENT C ATTACHMENT D ARCO Pacemaker Annual Report February 19, 2019 TABLE OF CONTENTS TITLE Program History Purpose of the Technical Memorandum Clinical Implant Status of the Nuclear Pacemakers Nuclear Pacemaker Accountability and Follow-Up Clinical Performance Analysis TABLES Implanted Pacemakers as of 19 February 2019 Explanted Pacemakers ( 10/15/80-2/19/19) and Attachment ATTACHMENTS Research Protocol for Clinical Investigation of the Arco Nuclear NU-5 Pacemaker Copy of ARCO Authorization to Ship/Relinquishment of Ownership form Removal and Failure Rates for Nuclear Pacemakers Pacemaker Related Explants 2

ARCO Pacemaker Annual Report February 12, 2019 I.

PROGRAM HISTORY Arco Nuclear Model NU-5 pacemakers were implanted in humans from 1973 to 1978 as part of a clinical study to investigate their performance. The pacemaker power source is a sintered Pu-238 oxide fuel pellet from which heat from its decay flows through thermoelectric wires and is eventually converted to a DC voltage by normal thermocouple action. Extensive testing such as dog implantations, impact tests, crush tests, temperature and cremation tests, and capsule pressure considerations were completed to ensure pacemaker integrity in the unlikely event of an accident.

During the clinical study phase, reports were sent to the Nuclear Regulatory Commission with information as specified in both the "Research Protocol for clinical Investigation of the Arco Nuclear NU-5 Pacemaker'* and attached "Contents of Sponsor's Periodic Report on Clinical Performance of Pacemaker" (Attachment A). The last full report during this study phase was submitted on October 15, 1980. After that, certain reporting requirements changed and semi-annual inventories were submitted to conform to the license. A copy of the latest inventory submittal is included as Attachment B.

In order to more fully update the Nuclear Regulatory Commission, per their verbal request, a report was submitted on January 15, 1988. This report, and all subsequent reports, will be submitted per Condition 12 of our material license and presents, in addition to the above:

Implanted and explanted pacemaker tables with relevant information as specified in Attachment A, '*Contents of Sponsors Periodic Report on Clinical Performance of Pacemakers and presented in Tables I and II.

II.

Calculations of nuclear pacemaker failure rate and mode as required in Attachment A, Section IID, and included in Attachment C.

A list of the pacemaker failure-related explants since the last reporting period and presented in Attachment D.

PURPOSE OF THE TECHNICAL MEMORANDUM The purpose of this technical memorandum is to report upon and update the progress of the clinical study of the ARCO Medical Products NU-5 Model radioisotope powered cardiac pacemakers from January 26, 2018 to February 19, 2019 as specified in the '*Contents of Sponsor's Periodic Report on Clinical Performance of Pacemakers." This is the fifty-second technical memorandum summarizing the clinical data to be submitted to the Materials Branch of the United States Nuclear Regulatory Commission, in compliance with license SNM-1993 that replaced #37-14916-01.

3

ARCO Pacemaker Annual Report February 12, 2019 III.

CLINICAL IMPLANT STATUS OF THE NUCLEAR PACEMAKERS Tables I and II list nuclear pacemakers implanted and explanted, respectively. The pacemakers are listed in numerical order with the fixed rate units first, followed by the demand units.

Information listed on Tables I and II are the pacemaker identification and any follow-up information required in the **contents of Sponsor's Periodic Report on clinical Performance of Pacemakers. Specifically, the fol low-up information is listed in items A. I.J, and A. I.M through A. I.O. Items A. I.Kand A. I.L are covered in the expianted pacemaker table. The information requested from items A. I.A to A. I.I is static and can easily be referenced from previous reports.

Information shown in Table II is also represented in the same format. Along with pacemaker identification are the implant service days and the reason for explantation corresponding to items B. I.J and B. I.K, respectively. Item B. I.K is depicted as a number, which must be referenced to the Table II Attachment. Items B. I.A to B. I.I are also static and can be easily referenced in Attachment B. Attachment D describes pacemakers explanted due to pacemaker failure.

IV.

NUCLEARPACEMAKERACCOUNTABILITY AND FOLLOW-UP Data from all investigators have been accounted for, except where patients have elected not to attend their semi-annual physician follow-up. The right hand column of Table I is entitled "Contact." A "yes" indicates a current physician/patient contact, "LTF" indicates the patient is lost-to-follow after numerous physician attempts to contact the patient, and "NI A indicates the patient has left the United States permanently. A "-"in the "bracelet & TD present" column indicates no information was retrieved from physician follow-up correspondence, indicating the patients had the bracelets and wallet cards on their possession.

V.

CLINICAL PERFORMANCE ANALYSIS Five goals were outlined in Attachment A,Section II for program analysis, and listed as subsections "A through "E." Subsection goals "A," "B," and "E" were completed by ARCO Biostatisticians on former reports. Thus, this and all subsequent reports will contain relevant information only on goals "C." and "D."

The pacemaker failure rate, as shown in Attachment C, has been calculated for the period from 10/15/80 to 02/12/19 and from program inception to date; columns.. A" and '*B respectively.

All calculations were based on data from 79 and 125 implants, due to one patient who left the United States resulting in no pacemaker service data. As can be seen in Attachment C, the pacemaker percent failure is 32.9% for the total program and 32.9% from 10/15/80 to 02/12/19.

This yields an average monthly failure rate of 0.0016 and 0.0024 for the respective time periods.

Based on the data found in Attachments C and D, there is no evidence reported of any long-term adverse side effects or other unknown factors associated with the nuclear pacemakers.

Additionally, there is no statistical evidence suggesting any deleterious failure rates or modes associated with the program.

4

TABLES ARCO Pacemaker Annual Report February 12, 2019 5

PACEMAKER ID TABLEI IMPLANTED PACEMAKERS AS OF 2/19/19 PACEMAKER SERVICE INFORMATION ARCO Pacemaker Annual Report February 12, 20/9 SUPPLEMENT AL MODEL#

PACER#

IMPLANT FOLLOW-UP IMPLANT TOTAL MONTHS SERV DAYS++

SERV BRACELET & CONTACT NU-5F Total DATE DATE 94 6/5/1973 2/11 /20191 DAYS+

16,511 16,511 543.04 543.04 13,403 13,403 MONTHS ID PRESENT 440.85 440.85

+ Implant days were calculated from the date the pacemaker was implanted, until end of the reporting period.

++ Service days were calculated from 10/15/80, until the end of the reporting period.

The average length of a month is 365'25 days/yr = 30.4 days in an average month 12 months/yr 383 days d

= 12.6 months 30.4 ays month 1 Patient expired on 2/11/19. Pacemaker was recovered by Jackson Memorial Hospital staff and is in safe storage. It will be transferred to Radiation Safety Associates, Inc., Hebron, CT within 6 weeks.

6

ARCO Pacemaker Annual Report February 12, 2019 TABLE II EXPLANTED PACEMAKERS 10/15/80 TO 02/19/18 MODEL#

PACER#

IMPLANT EXPLANT IMPLANT TOTAL SERV SERV EXPLANT DATE DATE DAYS+

MONTHS DAYS++

MONTHS CODE NU-SF 70 4/10/73 7/9/90 6299 207.2 3554 116.9 13 NU-SF 74 5/12/73 4/1/89 5803 190.9 3090 101.6 36 NU-5F 80 2/19/74 1 /5/91 6480 213.1 3734 122.8 03 NU-SF 83 4/10/73 8/1/86 4861 159.8 2116 69.6 03 NU-SF

.85 4/9/73 10/29/91 6777 222.8 4031 132.5 02 NU-SF 86 4/10/73 9/19/91 6736 221.5 3991 131.2 11 NU-SF 90 4/10/73 4/15/2014 14,696 483.44 11,947 392.92 02 NU-SF 94 6/5ll3 2/11/19 16,511 543.04 13,402 440.85 03 NU-SF 97 6/5/73 9/1/88 5504 181 2878 94.6 21 NU-SF 100 4/9/73 2/12/87 5057 166.3 2311 76 19 NU-5F 103 5/27/98 5/27/98 8083 265.8 6433 211.5 13 NU-SF 107 4/10/73 1/15/87 5028 165.3 2283 75.1 03 NU-SF 115 7/6/73 8/1/89 5870 193 3212

.6 03 NU-SF 120 7/24/73 9/1/88 1171 38.5 0

0 N/A NU-SF 126 10/13/98 10/13/98 9254 304.3 6572 216.1105 2

NU-SF 128 6/12/73 2/9/88 5355 176.1 2673 87.9 03 NU-5F 131 6/13/73 9/19/93 7403 243.4 4722 155.3 03 NU-SF 138 12/10/73 12/17/82*

3294 108.3 793 26.1 36 NU-SF 140 6/13/73 10/15/81 3046 100.2 365 12 36 NU-5F 144 7/27/73 10/2/87 5180 170.3 2543 83.6 06 NU-5F 145 9/14/73 9/24/81*

2932 96.4 344 11.3 22**

NU-5F 149 8/7/73 6/26/97 8724 286.8 6098 200.5 22**

NU-SF 155 12/3/73 10/24/94 7630 250.9 5122 168.4 14 NU-SF 157 11/23/73 5/22/87 4928 162 2410 79.2 06 NU-SF 175 5/14/74 8/1/89 5558 182.7 3212 105.6 13 NU-5F 318 5/28/74 6/28/88 5145 169.2 2813 92.5 25 NU-SF 341 9/9/74 3/17/95 7494 246.4 5266 173.1 25 NU-SF 342 10/8/74 9/16/87 4726 155.4 2527 83.1 22**

NU-SF 361 10/29/74 12/21 /81

2610 85.8 432 14.2 36 NU-SF 362 10/25/74 12/3/91 6979 229.5 4797 157.7 02 NU-SF 363 10/10/75 8/1/89 5044 165.8 3212 105.6 21 NU-SD 408 7/5/74 1 /15/82 2751 90.5 457 15 25 NU-5D 459 11/18/75 11/22/04 10,114 332.88 8500 289.42 03 NU-SD 460 3/6/75 4/13/90 5517 181.4 3467 114 13 NU-SD 462 3/3/75 1/25/91 5807 190.9 3754 123.4 13 NU-5D 465 3/24/75 7/28/92 6336 208.3 4304 141.5 02 NU-SD 467 6/4/75 3/21/80*

1752 57.6 0

0 36 NU-SD 474 11/23/73 9/30/88 5425 178.4 2907 95.6 25 NU-5D 476 1/27/75 11/29/89 5420 178.2 3332 109.6 13 NU-5D 477 5/16/75 11/19/81 2379 78.2 400 13.2 36 NU-5D 481 10/1/76 3/3/99 8188 269.2 6713 220.7 03 NU-5F 483 3/4/75 10/8/02 10,080 331.4 8028 263.93 02 NU-SD 490 3/15/75 8/18/03 10,380 341.26 8342 274.26 25 NU-5D 492 1/17/75 5/15/87 4501 148 2403 79 19 7

ARCO Pacemaker Annual Report February 12, 2019 PACEMAKER ID MODEL#

PACER#

NU-5D 496 NU-5D 498 NU-5D 506 NU-5D 508 NU-5F 509 NU-5D 513 NU-5D 515 NU-5D 519 NU-5D 523 NU-5D 524 NU-5D 525 NU-5D 527 NU-5D 528 NU-5D 529 NU-5D 532 NU-5D 535 NU-5D 537 NU-5D 539 NU-5D 542 NU-5D 544 NU-5D 545 NU-5D 549 NU-5D 562 NU-5D 571 NU-5D 572 NU-5D 581 NU-5D 583 NU-5D 585 NU-5D 587 NU-5D 592 NU-5D 611 NU-5D 623 NU-5D 624 Totals TABLE II (Continued)

PACEMAKER SERVICE INFORMATION IMPLANT EXPLANT IMPLANT TOTAL SERV DATE DATE DAYS+

MONTHS DAYS++

2/7/75 12/15/81

2503 82.3 426 4/15/75 5/8/02 9885 324.99 7875 5/19/75 12/14/99 8975 295.1 6999 3/14/75 3/9/81 2187 71.9 145 6/12/98 6/12/98 8470 278.5 6449 10/10/97 10/10/97 8242 271 6204 7/16/75 10/8/88 4833 158.9 2915 5/22/75 9/20/88 4870 160.1 2897 11/13/76 2/6/02 9216 302.99 7784 2/12/76 11/20/94 6856 225.4 5149 5/30/75 9/19/95 7417 243.9 5452 5/14/75 11/19/04 10,390 351.59 8500 6/17/76 12/14/81 2006 66 425 3/13/76 11/6/04 10,460 371.07 8788 3/8/76 8/31/93 6385 209.9 4703 8/29/75 1/31/84 3077 101.2 1203 6/4/97 6/4/97 7609 250.2 6076 10/24/75 8/18/06 11,260 366 9451 12/2/75 4/20/95 7079 232.8 5300 12/9/75 6/19/08 11,513 378.51 9741 2/5/75 10/2/82*

2796 91.9 717 11/15/75 6/12/87 4227 139 2431 11/19/76 5/15/05 10,344 340.39 8977 8/29/75 1 /15/82*

2331 76.6 457 10/8/75 1/7/92 5935 195.1 4101 2/17/76 12/5/94 6866 225.8 5164 3/4/76 12/1/85 3559 117 1873 1/23/76 3843 126.4 8865 6/3/76 11/16/88 4549 149.6 2954 8/4/76 12/28/88 4529 148.9 2996 7/7/76 8/23/96 7352 241.7 5791 7/28/76 1/6/82*

1988 65.4 448 5/26/76 12/16/81*

2030 66.7 427 479,585 15802.52 323,778 SUPPLEMENT AL SERV EXPLANT MONTHS CODE 14 36 258.9 03 230.1 2

4.8 25 212 3

204 3

95.8 6

95.3 6

255.90 36 169.3 3

179.3 02,05 289.32 01 14 36 291.31 02 154.6 02 39.6 22**

199.8 02 313.29 02 174.3 01 320.26 03 23.6 36 79.9 21 294.95 11 15 36 134.8 03 169.8 36 61.6 22**

69.6 L.T.F.

97.1 39 98.5 21 190.4 03 14.7 36 14 36 10448.26

+ Implant days were calculated from the date the pacemaker was implanted, until end of the reporting period.

++ Service days were calculated from 10/15/80, until the date the device was explanted.

L.T.F.- lost to follow NIA-left the USA permanently Pacemakers explanted during this report year are indicated in bold italics. (See #97).

8

ARCO Pacemaker Annual Report February 12, 2019 ATTACHMENT TO TABLE II CODES USED FOR EXPLANTING DAT A 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 Battery Depletion Impending Pacemaker W earout Patient Death Wound Dehiscence ( Opening)

Infected Pocket (Pacemaker Bursa Infection)

Loss of Sensing Function, Pacer Not in Design Specifications Competition Electronics Failure Lithium Battery Failure Nuclear Battery Failure Random Failure Delaminated Capacitor Lead Changed, Pace Removed Patient Requires Faster Rate Pacer Loss of Sensing, Patient or Lead Related, Pacer Normal on Return or Reimplanted Electronics Damaged During Defibrillation Pacemaker Erosion Reported Pacer Reported Not in Spec. at Implant, or After Implant, Unit Normal on Return Loss of Capture, Non-Pacer Related Feedthrough Failure (Advisory Group)

Pacemaker Rate Change, Pacer Out of Specification Pacer Explanted, Problem Reported Without Details, Pacer Not Returned 23 Lead Could Not Be Removed From Pacer 24 Muscle Stimulation 25 Elective Replacement, Not Pacer Related, Pacer Normal 26 Lead Could Not Be Inserted Into 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 Pacer, or Set Screw Could Not Be Tightened Pacer Rate Increase/Decrease Reported, Pacer Normal Upon Return Pacer Rate Changed, Pacer in Specification Loss of Capture, Non-Pacer Related (Plug Missing, Fluid in Terminal)

Pacer Returned Because of Cracked Epoxy Automatic Rate Equals Magnetic Rate, Physiological Reasons Non-Pacer Related Oversensing Set Screw Head Stripped Pacer in Spec., Explanted Due to Apparent Pacer Inhibition Automatic Rate Equals Magnetic Rate, Electronic Failure Pacer Returned Without Details; Pacer in Specification Pulse Width Variation Due to Psuedofusion; Pacer in Specification Advisory Return, Pacer in Electrical Spec. Upon Request Loss of Capture, Pacer Related Advisory Unit Not in Specification Upon Return, Non-Feedthrough Related; Pacemaker Still Functioning Connection Problem EMI Filter Capacitor Shunt; Results in Low Output Amplitude 9

ATTACHMENT A ARCO Pacemaker Annual Report February 19, 2019 Research Protocol for Clinical Investigation of the ARCO Nuclear NU-5 Pacemaker 10

{DJCH 25, 1974

As of :~y 17, 19 7 S, ARCO Nuclear ca::-....an-1 ceca.ma AiCO Medical F:'o:::uc-..s u::r-~"'="./.

£1~ ArFJ<CC Nuc!earCompany

~v Subsicfiary of At!a:,ticAichfieldCompany "0 IOa _, UIC:-IUtlC.... -1.,,.,.,.. IWI&. II I.A.I -

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I3.

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CUe to t."le e.-c:e:isive airou:i~ of previous testi."lg, t.~e par:icipati.'lg r.aiica]

ir.sti:utiC".s are net re,:;ui=ed tc p!r:or.n radi.atic:, testing. ender this p~cc:ol, t.":e focc~l ?..U-5 pace.maker c:neains a maxir.u1I of 0.45 g::a.-::s of pluto.""..i..:::-23S (less t.,an 8 c.iries). ~e result:...-:q cose rate at t.":.e rra.~-n ?='int en the pa~'T'a!<e: 5':':ace is 5.64 milli.rads p!r he\\: and O. 37 milli:ac!s per hour at 5 03."l:ir.ete:s f:an t.he surface al~g tr.e maxim..-:i c:cse r.1.:e line. The ~b:el N0-5 pac::er.3kcr is availablE in two types - f~ raee or cenw,ci (R-.;ave inhibited).

Use of the magr.et in this protocol applies only to tl".e H::cel t..11-5 cemar.d type pacemaker.

The,vco ?:O.:cfoa: s::atis:.:.c.tl I?asis F'or Clinic.tl Inveseigatia, of P.ad.ioisotcpic Pace.'l\\.'!kers - August 10, 1973 l

Pa~ts i:=:* te of eit.~er sax wit.~ a ma.xi.":"--: -'ige o: 65 or mininur ac;e ~..:.Jl to t.":e age of.. a jcr:. '::'/ for t..~C! suite of :-esice."'lc::? ( special cases. r.c:e-1er, ',2.Y t::e c:..~s1ce.red c.~ an i.~divicual basis by t.k.e a;;:rc;:-:.ate 1.i.::r.si..-:g au~":cr:.:-1=== clc::?: er yol.::':ge: :=,at.ie."'lt.s) who:

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I~ is ~-:!::!.::-:~ t-~at i.-:;,la.""l-:.ati=.s of :-:ucl.~.a: paeo_r:-a.~e...rs

~.:2: :.~s s:.*+/-:* ~\\li!! c::.-.t.!.~l.!!! !er a.tout e... -c yea:s a.r..C t.~a:. t.*.e mi..'li.-:-_-: ::.-:.c :: a::.:s*1e cca.l.s A, a ar.c E unc:sr Sec::.on II is t:,,c-t.":..1?.!

vea... c r.c:-.-c::-*""-*,:---...::05-

-....:: 1-t:'!' t""-

5.:...:~ e..==-~ s-**-=:es ~

=-

"""'-;i

- -.i 11!'-.:.:.:! muc:::: r:"C:;i :.:::e, ::.a!:':"'..a::s.i."l exe;ss of ta., yea:s, c.~ to t."".e r¥"1:.::.--*a. 1~y le:--,:.:..,,..~:,......,';.... c:::*.... e ""UC 1 ""'"... _.,.......,--;,.,,.,.,.....a i*.....

r-i.-*-- -

-: --- '---:-----.l

~

....... c:..-.-.. '-".....

cesig:-1 c.-:a.:ac:.~""ist.:.::s.

Infcer!C c:-.se.rit s."lall t::e cbt:ai.-:ed f.:an all pat.ie.."'1t.s for par-.:..ci:aticn L-i t.~e prc:gra.-n and for ~e ult.i.'Nlte re.'t'CVal of t."le pace:ra."'.e: a.ft!r i-=s e..~-e= useful li!e is exc::e-=-ed, its failure or t.'ie CS!!.t:.'i cf t.":e catie.rit, -iti.c.~eve: oc::".JrS firs~.

'n'1e stu::v will c:cn~:...-:ue t.":..""e\\.:g::c-.:: t..'lis period wi t.'l* folla,;-i;, by t.~e cli:rics ar.d repc::-..i..'lC] to Al.'lIJ N\\::!e.a.r en i."l'planted pac:?:rakers.

In orc0 :- to ac::-..::-a~ly c_.pare the n\\!c:.!.ea.r pace.-naker with oonventic:lal ~~l..e:s sou.-.c bicst.:1tistical pra~..!.C!s reqci.re use of c:::t.""Ol gt"C\\:;S.

~L"1:!fo=e, a series of c:ar-~le c:cnt.rt>l patie."lts.,.it.":. C:."'!".-a.-:tio.:a.l pac::emar.e.rs of t.'ie same t;"jpe (i.e., de:rand or fiY.ec rate, bipolar or unip::,lar) will be follo,-ed.

The c:cntrol patic:'1ts '-'ill be treat:eci c'll'ld follc,..;~ using the! sarre procedure for patiene selec-..ic:i, r.cr...!.cal procedures, follcw-up, a."'1d reporting.

'1'K! ar.trol g:c-.. -;,,,:ill 1:e at least. as large as the r.uclaar p.:ia!-

rreker stur::iy ~~.

2

VI!.

f°urx:.J."T'e::~.!.:*1, c::::r.vant.:.cr.a.l tec:"-"'.ic:;:-.:es of paca-:-ake.r L,sertiat are to b.o u....,; *..;..

- - 1* t.:'- _,,,_. -* ~,,,,.. a...,,,..n.. *cn *- '_.,,,.,.,..~ '"g.....,...

- ioio...----*

_W._

1Y

-~ ___ Ii.. __ _...

... _._. "-e.

~ ---\\,,,6,,ia,..._*

Uelil*

t.'ie elec:-........... ;:.-...

aa:oc.s*., **, : -~ \\..a;ve,... e:,-.....:1 '; J:e ---1..1e

--~ --- *-

~*

~-..... --*

"-'-*...-..&..C&...i to t.*..at of t.':e :::ace.-:-ake.r (i."'l e.--;c:ess ci :.:, yf!~'"Sj and t:.-:at. t.~';!'/ have aP?rc;:::riat.e ~ac::..-.g t."'.:esholcs.

.ec.?1.:se cf t.',e 10 or !':'Ore year c:cal, it is vital t.~at: e.'(""..:S;e o.re ~ take.~ t:: use t..,e bes-: available le~_s and t:: ::..."":=..::~ t.':e ~s.: :=cssi.l::le :e~ ?lace:.,:..~t. anc: =:i;-.:aticr w-i:.-..:.r.. ~~ co=/.

Si:.=!! t.~..is i.s an !.-:*/es':o:.;at:.::.r.tl :ret;=a"?l, ~

no~==~-::..-:.~ c::..-..:.=3.l i..:.se,

~ c :s E==:a:e:?.:le t.~..at. a l..:..~..i. :.sci nt...~~ of leac: sys~":S :.:e t.:.Sed i."'l cr:::ar -:.:: li.~:. t.-:e rn...-::::e: of var:..:.bles in t.~~ ~-::.=!l ~ac:..-.; syseS!!!t' ar.d t.~~ C:a1/e.lc;: ~re==-~..i.~;-::.:.!. C.a:.a en lc:-:;~vi-=.:* ar.:: =~li.aci:it-J.

'al:l.e 1 s;eci.:i.es t.-.e p:~ier=ed laa,,:s to ce t:Se:. -- s::culc. ::a ::o'C.ed t:.-:at:. t.":e !:t:-5 f.?~"!".a.~e:.- is c: t.":.l!

i.'C.-.:;:ola: -::r;e.

as a of,.. -..:... i.,

a.

'::1e t:r...,e c: a..v..:s.:.:..-:; elee--=:::::e rr..:s-: be asc:.:-..ai.-.ed a.-:.d i!-it.

is l"lO'C lis":.::: i-"'l ':'a::le I its t:Se rrn.:st be a::o::rcve: L'l acvanC!

by ;.x:: ~"Uc2.aa:.

! ccu:::t e."<.::..S~ L, t.~e ju~;::-e.~-:. of the res;;x:nsi.b

?h:*sic:.a.":. as :.:: t:.":e reli.=..::::il.:. t'/ a.r.:::/or c._-:;:,a::.:.!:.ili t'J of ar. e.'Ci.st.i.~*

leac., i<: s::::-.:lc: ce ra,;,lac~ ::v a r.~., er.a l.is-:e::.L"l '!'able 1.

For e."Ci.sti.~ le?:.S, aF::-=;r:.au aea;:t:!::S r.a.y l:e csed t:l fit t."'.e pa~.a.!;:er: ~-:ese s::culcl ~ of t.:...a t:'J:e lis~ ; :i Table 1 or

~==-.~ =-~ a::.*.*a.~~ ":y.~-':CO ~'\\:clear.

The t.~as:::::~=== ?3Ci..~g shall be t~stsci !:= al! elec---:C:es,.ne~-:e old er :-.e1.-1 a.~ t.'-:2 :..:..~.e ot ~ucl.ea: ?2,ca-:-.a.<e: :..~la:.-:. :=:":.::~ to c:.--:.ec:-

inq t.':e le~ to t.~ Fae::.":".?.~.

CT".ly t.-:cse lea~ r:.ay te uti.!.i:ed in w'hi.c.~ ac::~:)t.:!.:le t.:-.:estolc:s a:e ce.'?'C::--.s:::a-=e:: :-: t.":ese tas:.s. ~01:-

a.ble t=...~lc.s c=!".d test p~ures a.-'"'e c.:.sc.:sscr-else... ne_""e i:1 t.~

prctoc:l.

It is i.,:;:or-...3..'lt t::) note t.~t car-"; n infc.::-.at:.cn be obtair.ed and reccr.:ed prior t:l a."'ld at t."'.e t:...-e cf irr.;,lanta t.:.:.-:.

It is, there.fore, nec::essarJ t.":31: t.*.e.n.~tabilit:j' a.nc :rtr;,lant: Cata FoJ:m Ca copy of which is Fi<?J,re l) be fully st:uciied ar.d \\Jl'lCe.rSto:x:. prior to pa.rtici-pati.'lq in t.'ris clini.C3..l st:t:c.y.

The N0'-5 nuclear p.?c:e*naker is supplied sealed in gas pe!'ffl!a.ble plastic c::uble c.l;s.

Steril.i:::at:.cn procedures prio: to shi~ing are 3

l I

U1 -

';:ti 8 u -§

~

.. --~-

.....,.. ~.

'mu: I Sys:.e.'l'l 32.1-451

~lar 322-256

.Coe"' rcial

~~lar 322-~20

.S:-::::oca.. ""Ci.al

~~lar 322-25:i.

I

.S:-:cocarcia.l Mc:x:;:olar I

322-261 I

~::x~.rci.al

~~lar I

322-2Sl I

2:".::::carci.al

1::nc;:0lar 5814 I

~~c.2rc:ial I

Bipolar 5819 I

E:-.coca...""Cial I Bi;:olar 6901

~==c~.. :ii.al aipolar 6907 I

=--::::c~~:.ial I

-;;:::c;:clc.r 6909

l.

To u~e a. leaci or a2?~ not ~t.ed,

~.Ktl ~'.lc.:.ea.::- a;:;:=::-,;al is ~ed.

2. Fer bi::c:a: lea.cs, t:.se elec--..:::x::es wi.:."l l......... s-* _,,,..,.. -~ s-;_.,....,.._ *"'... """"ho 1 ~ o.= _,., -

~

.... **'--~---

'--'*d.i..l.Cil~~-

3.

Fo:: :_1._a C:::=.:.s 322 ser:.es, leac.s iss or 620 a:a F=a:er=ec c:-.:e to lC\\t.e= stir.ulat.:.cn thr:!sholc.s L"l sa"l.e:al t."la."l leads 25 l, 261 or 281.

4 I

None Mc:*.e I

~

I Ncr.e

. }!c:".e I

c.crc.is 331* -

I C.cr:.is 331-c.ort:is 331-c.:~.:.s 331-Cc::.:.s 331-

............. _."...,~......,,,,_ *****~,..,.,..........

~..... -.~.. --. *-***--**.... --... -...

'fUCLCAII l'O*Clll O c;.lllOII.C,AcCI.U,&l*

,,.._.. **...,-:=-----------:-=::::-:------------

~- i..v...,. ------------------------

c.,.. ______________ "'------l*-----

- - - c...... -*,........... - ---------------------

*------)l~Ml'-------1*------

.....,~..... r *...-w.-

~.. ------------- ::,,. ____ ;., _____ _

"'"** '4;1 __, '* '.......... ---------------------

~~.-.,.:.a-...... tt"""........ :.\\I..............,.......,.,.........,..............

- - - c:........ f#..... -.,..,.. ---------------------

°.. *-----------------------------

c.... _____________ ~*--------l*------

.....,........,...,~".......,. ------------------

1.&ectt,. ----------------------------

i.1 *** 1!""_....,,_: -------------------------

r-:.~........

-.*.;,*CA ~~.:'Ill",.:Cte*..... ~ Ilk 411**

,.* -!' -* ~--*-=-****,:....

,...... 'WJ....... ~

s:,.......... O\\ ****** *-~:

.....,~_...... ---- *** ::...... -----

s..-........... * * ;: -11 ""*,........ :

- - , *.-¥..,,.,.. - ---* a:,,,... -----

T~~

--"...,,.*~.: c.., _______....,.--. ~.. '""'-------

~...-:.....

L~lottw.. __________________________

v-----------------------------

0...*........ _________________________ _

...... S...""1:H9............. ------------------------

Uf..\\Af lC.A:l L.......,_.,,....,..

t.l1>fft Na i.-.- wa

,,.... --~ --------------------------

Ir,:.......

Cftllw**--~...---,------------------

,......,.,.... (re,,,...

.. _._,........_..... --..-0......, _________ _

- *---ca-**-------------

-*~_: ________________ _

CI.NnC*~ oara

,..,_ *,.,,. r.w _________________,.. ------

c-..... __ ------------------------

n...,-...... --------------------

................ o **,.. ________________ _

&.-......... *......, *.......,..,.ic.-

c..1..........._......................

w..-.................

Ct.,.................,...................-~-.........

=-------*-----*-------------------

v:::.

IX.

?!rfcr:::!C :..-: ~o~~us e~"':~/l~:1 cxiC~. :! :.'-:!! c;Jg is f::ur.C to bi c;:e..,cc or ac::.::.:~:::::.J.lly :-.=:..:.=..:-=. t.'"::? r.uc.!.e.a: ;:.ia=ake.:.- m~y be re-sm::.liz...">d L~ e:.-.:,~er.e CX!c:2 g~ at. t~~.at:'.!:-~S no-: t:, ex~ SO*C.

F'ollo......:.g s-:.e=:.::..:ac.:.:::-. a: :east: i2 ::c...:.=-s s.riculd ela;:se prior to

~~la.:-:~t.:.::.~ 7 allo..., c~:C!ta aera::i.::n.

! a ~..a::::o.-:--~er :..s d.tc-:::ed,

.::..:. s~cw.C: ::c:.:a :.-:-_;:.!.a:::ac t!..:4:,.:..-..s-:~.ad, =-=~....:...-::;d t.::.:JCC Nuclau.

~- c=~=

=~:a=:--:.~ i.! a ~a::i=..:lar :.=ad c.a."'1 ~ ~ad ~*!it.'l t.'-.e

~-ac:s.~.:i.. :::, :.:.s s-:..:..~~~=:. ~--=;s."':=l:! ::--=s~ =-= :7a.!.Su:ee ar.d

ci:.-..:: :.o ca C:*::;-:.::...:1..e :.:-. ac.:.=.. :.:=:: ~: r.e~t;..:...~; all. c: ~-:!! z=rc1.ric-~1r ci:.s::.:.:zz:C =-~.:..:.::..-:-c;-::s *. ::~e st:..:..-::-..:.!..a.'::.::: t..-:=~s::clc. ::-..:s-: !::G r.eas..::ea a- -* 0 t.,;._.::t, c.::. -**-~ 0 -,.. -:..l""IIC!-'"!':.,e,.. "-s~,..........-.. "-t*- --*---- *-

,....._,.,...... ~-*~

... -*- -*- - **-----=-- :"'"-............ -- - -*..__ --** _

...... :------ '-...,; ----*~----*

t:, t.~~ ~:.-:-.a.~:2=.

.:.s i.-:-;c:--:5.."'lt: ~-:a~ ~t:.~ c..:...-=a.*::: a..~C *Jelta;e 51:.:..7..:.:a.:.:.= ~--~stoles :.a r.-ea.si..::eci.

r: is also i.~:-:a-.:. t.9:~t bat::a:-t :=-,e::e. :...--:.st:'..=ents l::a use-: i.~ t..""--es.:olc :re:1su:-e.~.,~ si.-.ce t.~ e~;:,:see l~.!= ~;:;se."1-:.s a c..i:ez: c..:::-e::: ~~t.."";. t= t.=-..e hec-: a."1d e,,a.~ a :-:-.:...-:..:~ ?.::o:-:.-: c: ::;a!:::;~ c..:==a:.~-: =---*' ?='**:e:-- !..:...-..:!s re;:-ase."l'C.S s-* -*- ~-. --

~,..

c:=a:?-::.:. ~= '=~-.s=a::= t*/l.;.~ ac:*..:s-:..::..~.!.e c:.;~li.-:-..::.=.;; a..~: t.,::.C::.~.

~e

<2li:.::;::d ac=..:.:~::--: sl":c-..:lC be a~ !e.a.s~.... 10\\ a..~c: ~:.:= pulse C~~tiai sr.c.::c !:e acj.;su,,£ '::: =e L~ t.-:e ra..,ge oI o. 70 co !.

co millisec=."1C!s.

T.-.e ?"..:.!Si! ge.~e=~-=-== =-~~ shc-.J.lc: be in t:.:."":e :ar.ga c: 63 -

80 c=;::::i.

T.:"le ~~i.a:.:.:1e ~=.:..."":..al ci t.'":.e pt:.lse ge.~e:-at.c::- i.s c_;-::ec:ed to t..i.:e leac v:i~~a t.'-.=::s.,::!::: :s l:ei..":;" ~as-..:=~ a.":c ":...':e p::s::..'=.:..ve t.e:::ninal o: t.'":.e r::~e qa.-:~a-:..:::.:..s c_;-:.e-=:a-: t:o t.':e :i.r.c!.::::=~~ :.eac: whic."l is place:.:..."": c::::.:z~ ~*.i::.-: sc.::;..-_--:.?.":ec..:s t.:ss.:s.

i\\"!.:.'":. t..-:e cut:;-.2t am;,lituce of 4:.*.:: :..:!.se ga-:.!.:".:.~==.!...-.. :.:::...al!y :iat: at a;:?:-ox:..-:-c:.~.::y :g:o, t.'le a.-:-;:l.:..-:*..:~ is ~=*.:.:.).1.*.l ~-:==~=s~ t:..~t:!..! c::~:...S~=-~~ ~?-:-.=e c.:=--::s.

Tr.e c..-::;:...:.:~ c:::. *.-::-:!=..~ c:~s:.s:.. e!~::. ca?~=~ cc:-..::s is :-ec:r:ed as t.-.e St:.:..-::.:.!~::c~ ~--==~~clC. ~, c-..:.:::~~ t...:.....=:stol~ a.~: vcl-:..!qe t..~-ashold val1..:~s :;:al!. =a ::-east.:===. a::.C ::,;:c:~. :: =.s s-..:.;;as":..:C t.-:a-: an E:~=====~= :e l:Zaci ::= c::se:-,e c-:.sis~~~,:, ca~==a a.-:C :.~t t.~e cut;~~ of t.~e ~.:lse ga.~a=a~== sae at t..'-..:'esholc val~es ce c:sarved on an cs.:i.!:Csc=?S a..-.::i :ec::r::-~ W'it."': a s~e c.3.":".e..ra.

Only t.~cse elec--_-::x:es may be utilized i."'1 \\,~ic.:O:. t.~e m:!asurec!

i! r.awly ir:;,lanted

(\\,-:-.et.~e::' e.~dial t"lresholc is r.o c-:eat.a: ~:.:.an 1. 25 r:"a ar.c: O. 90 vol ts or 2. SO rr.a ar.c !.: S '101 -:s i! c:!".rcnicallv i.r.?la.'"I~

or~~all.

In orcer to i.~e acecuate cata for t."lis s:-..::.::.y i~ is vital that the Ac~abili:-.* c:.'"IC !.-:!a..,~ Oat.a Form (Ficure ll !::e c-_ *.:..letc:d prC!!;tl~it a::a:: e.!.~ ir.;' l~t:.at..ion and c!ist:."i-~ted wi :.":..i:. sovcn cays aft.e..::" i.n;)lant:a:.io as folla~-s:

6

~

Gree..,

Blue Opuati.'ig Pan~

SUrqC!Off I S Ct::::?/

?atie.'1t:' s Medical ?.ec::)rd AR:D '!-cuclear C...-r;:t C?re-~~sed ands~

t s::culc! 1:X? r:oted t..":at ar.cr.g ot..":.er t.'ti.nc;s :.~ p.:lsir.q rate of t:

p.acz:-..:J.:::!r shall ~ rr.:?as...:.=ed anc ;:-e,_....r~ o.-: t.":e ;..c_._..:.'1-=..a!::ili';:y a.nd

!."T":?1.::.-:: !::at.a Fer:: i.."::::-c":;.:!.~Y u;:cn.i.=;)lan:.ation a.-i:: 12 -

24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> a.=t~ ::...-:;:l..a..~c-:.:.:~.

-:e r:>.:.::?s s~C".llc:: :e c:-~-::::.~ :y a :=-.:.!.se 5.r.tz:",aJ.

na:oc::-*-~ -- ~*nc"' a,...-.-.,,..,,........ 1....., ~: c:-nd o:

0, culsas cer

. ----*~

~ -

.,......L.....--.....--*

~~-:~.. I:.:.s r;--... a~=e:: t..~at: t..":e r.c:::::::tm:.a.bili:-1 a.""C :r.-:-:;la.,t: Data Fo::: =::! ra~ne:,cd i.-: Cet.3.il =i*ior ~ ca:--=.:::.~t.ic:-i L'"l t.'-..!.s cli.."'Uc:al s...... ;....... ; -.s*-......,, _ -1, c.*a:..,,.. _...es:.,.,.;.::.s* c* ::t.3.b-ed a.....d -=:x:-ed c:.--.

- ~

C.

-*=--":,-*~

-"'":""---*------*, c::**-,....;,...,, ----~---:.

-~~---- ~-~'-------

,_-:._a,:;..:~--*::_,_.; __ --..,....,....~

.......,.....:!:l,

~

,-1 ~---:.- c- ---=-a,**c:-*-.-

Ca-::.e c:

-*-=--~.--- -- -..--- -------::,

!~~ -:.::.:;.-: c= e.!.:'=!.:':Ca (if as;:Ecaole) c!

F.

F..ist.::-; of :=:;*.ric...:s i..~la..-i.~, ra,CV"als of pace:-:-a1<e:s er lea:!s, a..~ ~.!Sc::.s=== s~c:-:. =e.~J'als *

. ;t i.--::.e:12.l.s of e,.,..e.::-1 t.-:.=ea m:::::..-.S Ct:i..~; t.-:S fi.:s": :{ear a.~ six rn:l.'1t\\..s t\\o;e!"=!ute.r :ollc... i:.g ~~clear pace::-.:1ke:- irr;,untaticn eao pat:.e::~ shall reo!'!ive a follc:1-up e."'Cami.......a.t::.::n a.'ld t"!e result.:..'1q cat.a shall ?:::e ~r--~ t:::, A.~ ~~clear on t.~ Follow-Up Cata Foe (a c:::py of,-.hlc.-: is Fiq-..:...-e 2).

'I'ypic::.:tl follcw-up da~ incluces:

A.

!cent:.!!cati.::."1 of F-J.t.ie..,t, pacemaker, hospi21, physi::.an B.

Oate of ilt;?la.r.tation ani follc..,...l.'? e.'21'Ri.nation

c.

Pe.....-forar.::::! of pac~_a!:e.r includi.-:g st.i.-=.:.latio:1 ra2 (wi.t.i. and without r.aqr..c!t, if a9?lica.ble)

o.

I."ldic:3.tion of any r..tlfunctic:i, no:lifiaticns or repla::.e.-:ents of pac:?!!'..i~ or lead 5!'Ste."n 7

/.':', r-. i.,.--. I."'~,, *-' - --~*-*-~.,, -*-" t

/.~ *.:.. 'J"°...,_..,_..,; i \\',"-"'._,..:;:.::,:: t_.,..:_..; I t; _;c,; t y SubsidiJrv of A ll::mticRichficldComp~ny

, 0 IIO&!>><IC/1.LLC:l*UU*C.,,.,*,::;v1,v..111At.... l,G,u.:;A,..,t(p.. ***~ ""'~*lllf FOLLOW-U? DATA FOi":M

("l'o uc ust-d each time P.lt,ent is c:on1;ic::,:d and/or cx;anuned including tefcohone tr:insm,uion ct ECC:.J PATiENT fDE\\ITIFIC.l TIC~J SliEei

?~;;cnt N.me _______________________________ _

111,,...

P:ticnt Hosor::u rittord No.--------------------------

ia;am,11trr S=-:-1,1 No.-----------------------------

C*tc ot fm::.n1u,on ____________________________ _

C*tc nf Fofl-,w.iJo _____________________________ _

Name of ?~*;!*e:;n -------------------------------

..:.c~reu _________________________________ _

c;,.., __________________ State ------- ::o ___ _

Arca Coe:,.ar..: rcic::ncne I.Jo.-------------------------

P11tient hu 1.0. C.-,o:

Ytt ___________ NO--------------

P,111ent is \\*.*e.:,ng l!:~:~ll!t or its Eoui*:alent:

Ycs ________ No*-------

C~n:ac: n,.a,r::a,n.?: 1*:;t.., :auent: Yes _______ No ______________ _

s.. :is:... ~.::*.. --------------------------------

L'ns.1,ist::::0:-v _______________________________ _

Stimula1,-,:, ~.:!:

v.-,:n.*.~.. -;~tt --------- \\".'/O r.~.;ne: _

Clicn,;.a !r.l1T1 :.rev;ous riltlt --------------------------

Char.;: fro:-:: i:,i.:.al r:::e ___________________________ _

Summary: ________________________________ _

Re:,osition: P:c!~,.aic:cr, ;cad/1::ilh Rcuon ___ *-------------------------------

Ex1>i.:ini.:i1ion: Pac:::-:.::i.. c.r ;tead/botn Reuo"----------------------------------

Autocsv Re:uus (if ac;,ticJblel _________________________ _

C..usct of Ouch (if.ar,gtic.iblcl _______________________ _

Ti~*------------------------------------------

0111 ______________________________

Sign.-.tur*-*--------------------------------

This form sh:,uld t'~ c:;mr:ll!tcd ind "rurn,a to tha n~:u:f::t:tCJtttr within 10 r.';vs of r:tkmg follow-u:, d1tL For urgent questions ::n-d for.::ssist.:nc:e c:011cernin9 this r:iccm::'ccr, plenct t';:fl 4 t 2-C.:S-o 111.

$.. I Hete Aflv,...,,..

8

c.

C.

"'!dic:s... :-:~!."':e: ~~em:..:.s car::-/:..."":g n car.: a.nc: *....-:a.ri."":q

rac:?le:: a..~:: *.. ~~c!:.e: c:~=-.l~ '.v'l :."": :=a~:,..,~ !"":as ~""l ~ainta.ine!d s1.nc:e las-:.:::1:.0.-;-1..:p 7.-:.e f:;l:c.:-*:- c:.a~ s.'i.all i.'1cl.~e ::ulse i.'1te:-:al r."t?.asu:e."!'l!."\\:S fu.si..-:: a (;.::*.. -:.c:-? '::!~~ a -

l rr'.!.l!i.s~c::.-:: c: O.l = ac::-..=ac:} ar.C: a

=~c::::..-.. ; c': ~:a el~c.--=-:.-.-~....;-i.:;=:a.-n (\\vi t.-:.l:'".C \\*J:.:.~cu-: t.~e r.-.l~!1!,

.: a:--;l.:.=.:-..:::?l.

-:e FollC".1-t';: C.!~.a :::=:-:. s!ial:!. ~ c-:::;:h.?to!': a.-ic!

-e::.:::-~: :=.:.._::.c:: :~:.1.2.a: ~*.:i ~:..:.:.. ~ !.~ c~~'s ct e.:ch e:~~

.. ::::.c.-..

In ac:::~.:..~, :.-:~ :,:::=.:-~-;: Ca:.a t==: stal: be used e*,*e~r-i..73 t..~a r-at.:.en*

is e:*:=-~.:..-.:'i e;-:;~ ::..= sue..~ e.'=c..~.a::..c::.s ~::! cl.ac! r.cre cf~a.-: ~a.,,

.. :...,. c:-=.,.. *.:;,,..; e-::.-*::,,..,-,.;

,..1

~..,.,.:.,..,1,_.; t::"'--~csi*-.. 0~ C',..,..*

~

..... _,*-:.:....~~ ---~ -*-

~--

.. ---=::a*

-:a i::-;-..::sa =:-:~ cf t..":e ~ac::!':"a!.:~= *... "i.ll var! i.~ a ~::-:e.:..=-=aole rra:-~a: c~~ ~ :-?~i.=~c-:.:..._.. e C~c.?1** ci :..:-:~ :~1 a!:C c::.-:se-~a.-:: 6:==e.?Se a=:::.;-:. ;:./ <;.:-:-:1=:..-:; ac-::..::: a.~=. s:.:.;::-:. =~-i.f:-:.::..=..:::..:~ cf ~:.:=.-.:..:. ::ea:

c.... *.. '::.~:.:: :.~; :::.:.~-:~.:-./ ca-...:.sc:-: :::::~ \\,*:g!::-:::.s ~~::.:.a.-:-: ;::~1si-:a.l cc:.ivit:-/

\\-... :-.:..::-. c::~=: :..::sc: :-a-:3 t.: sl.:.;::-::.::, :...-.=~::se a..::.::- i.:::;!a-:-: a.r.C :.~e.~

S----~:-..

.-=.----""-*

-:.... :.. e.

(ei:.-~ wi-:..~ er wit..~c:-.::

t.'-.:! !""'.:i~~:.? c!e*.r:.a:.ss f:c.-:! t.~e :L~i::..al.:,-3;3 re=:::.:?= a.ft.::.:' ir.:;1.a::o:~tic:

t:::* r::.=:! ~":.!.~ : ~~s * :-er rr.i:!1.::.:i, ~c.:; ::uc!e!..:' s.:...a..1.1 ~ r.c-:i!:.e:

.~: a1:~l:*. :: ~'-::a E=._ll~e fails to ca9::u:e \\C~..;:g n::-:-~~f::ac::~,

~~ases c: :.~ ca::.:i.1c c.:*c.1.e), ;.:;c::; r-:ucl.ea: s.-:al!. ta r.c-:=.:ied

~:ia:.el:*, c;..-.C. ~~s i.. ;.~,*es-:iga~c:s s!,all s:-S:.:.C to ;:..:.=s~e t.*.e etiole;y, lcc.1..:.:...~; l:ot:i t.:, ?=':~.;.=i.i:il :a.:.1.:.::a~ e~::e=..al t=> t..~~ ~.:c~-:-ake: ~C: to t..~:! ::ac:::.-:-~-:e:

E.:-:l~-:ati~

?a~.:?.lte?:: \\*:+/-.l.: ::a r:..":"C*Jec i= c!i..."'::..c3l.!.~* :...-.:..:.::l:.~ Cue t.:=

fail-.;_~, rral!*.:...~=-:i.c..~, Ca11elc~t: of i::~c:!ssive c:::=...:::i :.:..:..-: Cec-~-i t.~e pacena}:e: a.~c: r.cr::-.a.l c::::r~uc:ed l:;ea~, t.~ cea:.'i of t..~ pa:tle.4:*,

t.~ antic::.;:.aceci e:-:.'lausti~ of t.'"'.:! unit. or i! t.":e face.'T'.:!};e:- race C:"~;es by m:.:e t.'-.a."'1 10 pulses per :n:i.nut.e.

t*~e.-.e".ar p.::ssible - i.e.,

1o.nE'.:1eve:- t.~e p.a-=.:..ent' s welf a...--e is not c-,-:,-:-=.:.sec! - Ji~ ;;uclear will be cc::-.sul~~ crier to t."le re.'!'CVal of a C.71C~<e:.

.nv cac: erra.'<er or lead we is e.~l~-:ec or re;:csi ~c:-..!e for a."":y =aasor. shall be raported L"l,,-:-:. ~~~g wi. t."lin l we!!.lt to ~.FCO l\\,1elea:-.

T.ie repor:

shall facl1...: 0 r'?Mcr.s for ac:ic:, t:ike."l, cate of ac-...i.on, and associated tes~ pe.rfo:m::c:.

TI1e ~e!'!".!..~ a."\\d, i! pc:ssible, t..11e i."lt.a.C: lead svstc:: shall be re1C11ec! t..-=on CC3t.,. a.r.d retl.!..'":'lcd to ;;;;co ::uc:lea.r for

~al~a:io:i. I! r.o aut-:-:=s;.* is p.lrfo~, t.'1a tn..""'St pro!:.!.!:la cuse of c:;.at!1 s!ia!l L":? s-::.a~ec.

Aut::sv fi~:.L.,cs Ci: ac::::lic~le) rC!l.1teci t"' t.":c p;,ioar..:i.ker s:1a.l.!. b! ra~r::~ ar.c. if pcssi!:>i~, t..~e f..:.."lc-...i.on of the pacc.'!'.:.~e= a."":c le.ad systc."'!1 will ~ cetar::-.ir.ec a1:. uu~sy.

All nudc.1.:' F.l~..1.~C!rs th.it are e."Olantcd for a.ww reason shall b:! rot.t:..."':".QC to.\\!,CO i\\\\.:c.!oar as s.::.cn as ~ssi.ble in a shiP?.i."lg pa~qe 9

XI:.

c: :.

Cl.

sup;,lieci l:y AiC'J :~c.!.P.ar and i.~ aco:r.:ance wit.,. la.!:x?li."'lg and s.."li;:?i.."'lq i.....st:...-.:::~:::ns al!.O S1..""9?lied l:y J:* *.rO Nu::.!.ear.

At e.-cplantatic:

the r:\\.:c.!.e.a: ~.a;~a: :-3.t:.e sr.a..l..!. :::e r~r::od (W'l.t.~ a.~,..i.t."lout t."'.e

naqr.e~. i.! a.:;:?lic.:.:::le} rl.iXi ;._:c; :.:.Jclea.c sna!l. !::e cx::::"'.sulte:i, if

?=SSi!:le, :: a,,:,~; :.:.:::-.al """'S:S ~ !.:.:? ~:::::::-ad.

.7-;

:,n ~:-.;::.!e:: c..-:c '"'*e, ;.-,:,-c~.. :' a.cane-: stal, ::e **ct:i ;:: ed wit.'iin 24 !":c:.~~ c: -:.~~ c~=~~ ;f a.;;;-;~;~~... ~a~::-.!.~:!!?' ;~===-~, a.~~-a.'"!Y ac.*...... -c.:....,..,._~_ -.-,;.10,.. -,,,.j#**---*- '"\\""'1,,.;-- a -sc-.-.. ;-e... =*s-... -

~-- *-----* c.;... _,

WJ lii.i.**I

!..-:c.!:~c:..:..~; !.~:! 1~!65.

.~.t'~ :.:.J.:2..s.:.: shall ta ~c~=.:.~ -..;i':..~i.~ 10 Ca!*s o: !:ss c: =~= *.*.'i ~~ a ~uc:!ea:- ~~~"':'"a.:.;ar !:;.:.:~r..

cat.a a.-rl vital s~~st.:.cs ~~*ni.~g to t.~e

=at.:.~::~ s::al!. ~ ~ai:.-...?.:..~ as.:...-:::.:.*-*iC~a.l f!.!as r.uc.!.e.a: ~a~.a.~er e.:-'2"*~~.o.1,., ~............

--~-----..: -----

-~-...;-a.

~-e--* -,,

- --:'--==c::=::..s.

=---

..-::..:.:.:=.s:

c.

A f.:11~" e."'Ce-:-.::&.: C~" o: t.~a C::=:e.,-:,:; ":.-..::::::-Y-C:::.se.-:t !or S.:r;i:z.1 ::.~.!...:..~=.:=.!.c::. Of :.:.::!..::i~=~=?= ?a.. *:~~= C~-iac ?ac:~~.a.!l"..ar*

(a c:*;-;;* cf *.-.hie.~ :.s at~c."'::::-::.i

o.

r.cy a=i~:.~al i..-.!cr::-.. :~:t..:.o~ C.:=--:-ed i.1;:cr-:.a:.:: !:y t.'":!! mer-ic:al st.a!.:

C.--~::.----

ill t=.!:.:.e."::.S s::.al..!. s:.cn t.~e L-..:=:=e: c::-.sa":: s~te.~~ e."ltit1.e::

:..""..:':::::::e:: C.:..--:sa-:: :,:;: cu_:-:-~, --, ar:-=a.t.::.""""' Cf -::..a,.;;-; sot:e::e Fo:*~e::

ca."'"Ciac P!c:a":'.ake:" (a ;_;y-~fwhi~; is at~c.-~) * -O;i.ng t.'1.i.s..

ccc-:.e.."lt t.i.:e pat::.e."lt, or his re?r:?san.:at.::.*,;e s.'.a.ll be info~ and shall agree in wnt.i.,g to t.'"'.e follc.,r.ir.;':

A.

That nuc:!ea: pace.?:'a.1<.ers a.r3 ur..:::er i.-wes:.iqaticn, t.'-.z::-e are alte."f'lative t=eat::a'lts and t."'.e patie.."lt is will.L,g to pa:-..ici-pa:.e i."l t.~ L-:vestigatic."'l B.

'Ihat a!te: t.~ patien~*s deat..,, or if t.~s t.:Seful life of the pac:e:nake: is exec*~~. or i= it c,uses to func-....::.cn effec-...ively for tha patient's ::ec:.ical r~..s, or if t.'ie patient r~ts to ha\\*e the pa...~ai:a:.- r~ed, t."ie nuc:lea.r pac:e..':".3ker r:ust be retur:"~ to AFCO :;uc!ear 10

c.

~

c.:;;.:.~"e.... in,t.l\\*lcl','S c..:..r::-1 t.~e rD ca.rel.:ind br.:ict?fat ai his p!!'SC'l, a.ic: t:: noc.f'/ ~.e hosp1.cal of any c:~an~ i.n his add..~:

or t.ele;nc::e r.1--::er.

~

t=at.::.~'"lt *..;11.: ;:o~!j-, :.~:::uc;:-: t."":e hes pl -:al. a.'1d,\\ICC Nuclea:.

t.~e c.:.-::pr::-;:=:..3t.e :.:..::::.--.s~g a,.,;4:.l:::.r:.t:./ =.::ic.r -:.: a.1;.y ~a,.*el cutsiCC t.,C t:r..i ~

S :...1:..es.

.c... _~c,*led~""lt: . !.~at ~!! ??'=.:.e.~t !-:as hac.! t..~e cr:?=:-:-=..it::?* t:, as.1<.

cr~st.:..:..-.s ~er-:a::..i."":'; := ~~~ st:.:-:;ical ~=ocsciu::es, ::~claar pa.c::!.7.:.:~:.!.-, ::::.1...Lc:-*.;;: ?=c:2~..:._~5, OJ.id ~ss:..ble al~=.?.~ ;.et."'tcx::

of L-:::7.en:c.

C:;:::S c: ~--= s:.;:-:~-=. c=-~a:::

._~: :~i:..:..ear ~~:: ~~.:.~= i.."": -:.~e

":'7a s:lal! =e g:.::~ != 4:.-":~

=ac..s.."'l'C.

s r.eC.:. =ll ::le.

Al!. :~:.:.=l~== ~a=s..-:-~t:e:- ::::it.:..e.~-:.s s!iall ca::::1 c....~'=:?..~:ial.s ic:.:.~t.i!~*

c.-::.:..-:-. t:.S :-.'..:::!.;:.:- :=:?e:.-:-~-:~ ;~:.:.=!1~.

7:-:.sss c=:?:le~':..:.a:!.s \\vill ir:clu<:.a a.-: :..:Z.:.-:~:.:..:~:.:.=::==~=:?..:.::-: ~: -=.;:; :ia*::i.=~-.;:e=-= :::_.~ a.~d a \\*/Cl!et

-~ *,,.,--* -* -~-.. -- -:)~.

~~~--

~~l~ --i*~,-

._..., ____ _ a.-:: :...~.~ t:c:-:s ":::. t:..~!:';a"'!c_.: ~-:cs;:ita.li-(;:~::::5! r.:.=.::.er of ::c.s;:.:. -::al)". *,;

. i.~~.!: c: :.-:~ :..~-:-:.:.=.i:~:.ic..-: c.!.:": is F.ig-:ire 3 *,.;;:ic..~ c:::':a.1..".S t.=ie

.c!':.!.' s :-.. :..-:-.?,

~~2 :=.:f=i! =.=..::.:..at.:.c..~ :'!:-"!:":'::::l,

~:~ \\*io:j,:

0 ?.!:lic::uclic.e

.. _.::..s..-:-a-:-:. ~-:.::: ~':~ ;:.!':..:.~:::..::.s :."':~ i.~lcr.-:=.~ of a R:':!ciici~c-:...--;:e

'~*:a=='= c.:.:=.:.~= : ?,::;.-:-.2.:...er, ~ufac4::.c:ar

s ~;:.~ c:::! ~!":~-:!! ~

.. :.::ar, s:.s~-:-~~e: ::-cc.:.a 1. :-:.-=.-.::-:.:-, a.-:-c~-:: a.."'lci t":-:;:-:= o: c.=:t:a.:_r:~d =acior.uclice, t.:O::! t*.or:S 0

.-: c.us c: C.::::.. -:. !==:: C..'1;!' cZ?::.:se or e::-:=;e.'1C;' c: t.:~l:!A b*,"Olvi::.; ~ac:..-:-.a-~e.:-s t:.al~~~c:::? cell!?=-: (:,a::-:-e and ~":.c:-.e n~r of par-:..:.=::;s:.:*_-:; :.::.s~-::.:-:.:.cn a::c: c::::-=::r (s) L"l c1a_-g::)", ~-:~ wcrcs

"-~-~- *.- -:...,--,, I"-=.-:--- C"'1, c--..... -.-.,, *1;ucio:.... 'O:,...,.,.,.,,.t.,,... - '~-_-"'nt.1 ",

-~'------

-~---"'-'*

~*'---'-.. ~

-~

_........._,.._,....,~

\\.i4W*

a."lc. t.":.:? wor..s "::'.::-;ul.:::.:.c:-.s ~=e ria:OVal er ~acs:- ~

c:i:at."l. ':____J Bot., t.~5! br~o:?l.~-: a..,c i.ce.'a-:.:.:icat.ic::. c'\\:":::.... ill ~ s*..;-;:==liec: to t.~e par-...:.c:.;a~"lg L-.s-:.:.~*.. :::.::.cn by AR.::D Nuclea: :ollo....,inc:; receipt of t.i.:e Acco.::l~ili t:J a.--:c. :.-:::lane Caca FoI:m.

T:".e L-.s:..:.. :uuon will t."'.en give t."'.e braoelei!- a-.c ice.;tificaticn card to t.'"'.e pati~t. a.'ld remird t."l2 patie."lt t.::> a.h,;ays car::y tt.e.m,:n his person. If t.-ie pe!:!".a.-:ent bracele~ and ID car:: are not avail.:lble whe."l t."le patie.."l~ is discharged fic:m the hospi :.al, a ta.-:-;:ora...--y br.ac:el~t:. anci ID ca_"'t! a:r.t.a.i."'.inc; t."".e sa.~ in!c=~=-= shal! be given to t."'le patie..-it um:il t:'le pe=r..:1."lent er.es are s~lied.

For eac::::: pa:-....ici?ati.r.g institutim t."le t.:?la~1one c;:erators will be isscee t..'";e folla.:L'"lg ir.st.ructions:

A.

Mr:' c::l!ec:: calls c::::nc:e.rr.inc; nuclear paa:?."'.~a!.ers will be accepted.

S.

The c;::crat.cr shculd obtain as mud1 i.r.for.-at..::.::.-i. fran t.~ caller as pcssible incluc.i...'"lg:

11

is the,m::1ante~ of a Radioisotc:e ?owered Cardiac ?a~mai<er Rldionuc:irit 11 Plutonium - 2:?S < 8 c..,ries MN* OY ARCO Nuclur Comoanv Model Numoer is NU*5 SEE OTHE~ SIDE FCR E!\\~!FfCENCY INS~~\\JCTtONS ll*CVJllOIU rtQVVI remo*IM ol pacec.aacr \\IOOa Clt'alL FIGJRE 3 12 URGENT Medi ca! JlJert!

(0:11wnu<<I from,.,.,.,,. *itl*I 111 use of cfutft from 11'¥ Clllllt

ffl'le'91ftC'V or ttavma 111.ohlifWI 11-

,,,...,rs 1e11:l\\ono, =t11a. uw:

,oocfoL OR tOIIC,110111, c:ollea. tfle A

A.RCO I\\A.c:ie~

V l'12J 1,es.1111

~-*.. *-

lnnn,c: ;:11'\\oft* ooeraco, c.all --

Nuclear Pac:ar.-.aaer - U"'"

ll*cv.&allooa r1ovv1,.,,...., ol pac*=-** VPOO 4uut.

c.

!"\\

.. J. :! ar.y ~~ysic::.an is pres-enc,

4.

._"':-..c..:.. :..:.::::, c: ~c:?.-:-.a,j.(e:, ; t: '.-=:cwn ( i.. c., e.~llec er still

=-~l.lnt:~)

e,1~ e31*0: -=---.,,.<==-"'-

....... -.,,....,-,,.11v "'::.ve..-,..::'r:.,.".:'-:-c*os c:.."'.C......

c.:a::a=::- s::::::.lC :.-:::-~-=..a '":..:=l't c::~:.ac-: ~-:e.:...-.s-:..:.~....::::..=~

1 s ::..a=-:.at.i:.,

e:-=a-, c=:::._-:,_ :;,...,.; --,c:~--<::.._,.::I c.. _____...:....:io }"'(:C',-"",i-C' --~,-.111'0,..

... ~---- -*- ---':""'-*------

'\\,.

C:". ':.~! 1.::_~:! ~:_: S-:..!..-:.~-:,; :.y.

C:;a~:=......

o:-,.:"'St:"t --2.. -:W-

.:.1 '-'"!),,....":II**;.

:*.. ---- a....--**--

O!!!..=:= c= ':.~e :-.;s?C:--..z::::!e C!!':.::-: !:-a re!c..-:.!-':, c=.~c-:

s=::,s:..c:.a..~

~:.:.ai::

C.a:e Gni-; ;:::.ysic:.a!'l c:i. c=.:.-::1 a..~ ac.visa c:

si~.:at.:..c:. and

=~:....-:.; :..'-:~

'

as: c: :-.!:.=.:.:~ ::~'=~"':"'.::.. :a= '"..!S:!,

!..=<?::s:~ ~g =-~=-~; :.~s*..:a-i c::l.:., t: ::-~.: =~l.:..-..s:..::::.:-:i.=:-.s t..~a1:. er. ass=a C:::"::..:...~*..:.:..=.t o:==::i:-::-*...:? cf ~~-:i.;.;-=.:; t-.ri -=-~ i::-;:!=..-:-:.s~ :-*-a.-:1 ka=s =~:.~er t..':.;l.-:. 4:.:: L-.=..::::i.'=:.:~2. ::::~*~ :..c:..!l..-.s.

.~ lic::.-:se :...:s~SC 4:=: a ~-ical

.L~:..:.::.::.:.::: a~=-~==-i=~s a. s=~=::...:'!eci i:=lar:~:.::.-: l~-:i:. L-i t!!.:::"..s of n*-'....,..,.,,,,..,.,---**- f:*=~~~-..... -.._-.,,,....... -*,,,....: -,,.-......,.s.. -:......,_

........ _...,._..a

"-'*--- -* :'-\\,,;.-- __.. ----- :--...,_,_,...;:a Ii...... ---:.-----

-- _.,c;:-..l i:-.s:.::*..:~= ::: b..! n~-:c:-..!!i.=le for t..~e f~llc.:-t.:: ?:.:! rac-o'--=r'-' o! t:.":.!!

nu-l.,.,... -... -o-.:a,n-

...: ..,,... -.,...a........ ~............,..,.:,:a,.:... '-o l..iC"'"C"". r:"1--

... _____._ __ _, -*-=----*-- -~ =----"'--' w................ -*-

.,.u:

pcysic:.a.-.s c:~si~.!-:.~ as t.*.a :es:C!"'.sil:ls i.":.*:as~:.;-a-:.==s by t:..~e ::1:r...:.c:a.l L-~~ ::::.:.:!! s:!=-..:..; C :1ave s-~~-=..3.r.:.:..al '~:.e..-::2,,... i-:..~ ?<=,c.a.-:"..!.:.:~s i.."i

.":e s~:.a!.i :.:.~: c: c~~~lc-;:t anc! t.~c:ac!.: s-...:=;:~r./.

T:~e :-:cr1-ic:al i.:-.s-::. ::..::.:'.:~.!..S e:*:::a-=-::::. = r....:!.'/a ~ eswEs'.-::-: ::==°'=-=a.-:-: a.~:

a;:=~=:a~ :~:.::.:.:. :_:gs :::- t.* 0 i..~la.."l~:ic~ a:-..:: !:lla... *-~= c: c.a..-c.!ae p:ic~-=-~::e.."'"S.

a ::er....:. c.:u.

B.

I.nc::::=c:crati:., o: t:..-..:...s :-esaa:c.~ F:":tocol by re.:a:~ca wi.t."l a c::mit:::e."l~ to follc..r it.

C.

For e.aei Fhysici-=n en t.~e stucfy t~a.'?1, his narn:?, S?,acialt:'J bo.al:d cer-....i!ieatic::, priavic-.:s e.~e."lce in t.":e ir.;,la.,tatio:, and follcw-u:, of i.-::1,!.m:.:ible cace.'T.a.kerS L-..:luc:i.'1a ~::.eci.:ic iJ'lfc.~-

tion c:1 tr.3 cu:itic.-i ar..d ru....cer of p.3.:a.-:- 2 ke.rs i.~la."lt-od and/o::

follcwc.-d, a braakc=.*.n of hew r..any of t.~.i..,?la."lts us~ rn'!'OC.3.%'dia.l leads ar.c! e:~c:x:::=::.:..~ le.ads, urxi p::isiticn of t.:.O:e Fbysician wit."1 t."le a;:?lic.::..,t.

13

G.

I.

,\\ cesc:::.;:t:ic.-, of t.":e a;:pl.ic.i"'lt:' s p:~e."11: pace:!'ake.:" i."":T?lclntaticn and !:llc-.w-,= cr::c:':!.'TI i.-.cl!.!d.ir.g si:3, i:rp la.m:a :.:.::-.s :

~

cu.rat:i.cn and types of

i?.5,::-:.;:~::."l cf ':.-.~ ~ysical.:acili. ~:?S ar.ci eq-..:i:""".a.,t: availa::le fer i.~l.a:.-:.l~i:.-: an:i.:':l:c::-*..:;:.

':'hi!7 shou.lC i.~c.!:Jde specific

~st ~-:.:.:=-i~-= =~..:i:ed t:, c::J.::f cu:. :.:.:e ~-:s ci.:.sc:-..:.sse.:! in t.'-d.:.

r::==l.

. ; C.?Sc:i;:..:..=-: ot t..-:e a;-?lio..~~

s p~9C~es=== ac=--=*,,~il.:.:-1

~,: sec.=:.~/ aga.i.-..s~ less c:- -:.~~f~ of c.?.C?..~a~:--s b.:f.:=e i.-=::la.:::.:

~=~ a.-.= ~~==~"*al==~ ::at.:..a.~:.s.

C.::..... ~

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t= ~-=.1li!!.::: i.-~-:.:..:::-:..ic::.:l t."-:~t,-.:ish t:> c:a;;ly ~ r:a:-:.:.ci.;.a:.a i.~ t."'..is s=:t* ::-:=.s==== ;-.,ill facil!.:..:!~a ra?id :===e~ssi.-:; c: s,~c.-: a;;;:l!.-

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ClFOi*.*~ o:sr.:r :""'~ S"1.1~lCl. :=-iP!..'\\vrATIC: OF PJ\\InOISv-rorc ~-."F".. ~.m C.~"'.OI.i-c ?.~~:r:n I ~C.C::s:.z..~ :...i....;1t. :::r -:..~~ t:e.!w.....::r:~ of ::'!f car:.iac: c:::-.diticn - a Cis~:::2.. ~=:! cf ::==.:!l c.::::.i~c c-=::Cuc:-.i=i -

a c.a:c!iac ~~il!-:er is to be

.::.::-;:lant:sd :.., Z".'l!.

also 1..::-:c::.?:s::.a.r,.d t.,at: t.~e surgical ;::o:ac~a (r.3"J/will

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~:~e ?:-:::ecii.:.-a

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,--~..--* --

I hav~ ~ea~ tcld t.':.lt. t!~e pa:~::-..:;.t::: C:si~ ~as :e-e..,, e:~a;.s:.*.*aly ~st~ over a :=eri.CC of s:*:-::-a! :"'~.1..-s.

::~*:a =~a.~ ~=~C: t.~: c:: t.":.:! !:3..sis oi ~~gss e:*~a:'i.7a~-:.s i..-: c..-i.:..7.:~s c:..-:: :.._-: ~-:; :.:*-c=a:.:::-:*, t:"":,:.ts o: t.~.:.s t-.:?- are p:-acic::d to

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t.'-:e :-~s'.!!:S \\-.. ::1ic.~ ::-.a~* :::1:.~.:.

! 1.r.ce:s~-:: -:...=-:.3.-: t..~e Fa~.:..::e: C----es p:-==~~ :-a=..:.:::..:.::::, =--=-= ! :;a\\'e C~"1 tole l:-f :'::' a~:,a.~:.:..-:c; i:.~:*sic:!..!..., ::..*.at it is t.":a ::t?:..:.cal. :e:;:-~'11:. t.-:a-:. t.~!.s rac:.:.c:it.i=. ;:=5!sc::.-:.s a n~!.i;:.bl9 ha.:a:: ~~ ::n c:_-:: :..-.,: :-:-:?.17::.;=s of -:::.1.* hct.:Sc...~ol:!.

':."':a-:.:..., c-:::.s~~-:.q t::i t."'.e i.-:;;:le.-:.at:::.'=l cf ~"'I.is f.!~a:-:.e~

! ~"' cl?.:~:0:::i.::..~;, as *.. :al:., all s~f.a:-: c~ra-:.:..~;- ::==~:=!!s, i.,,c:ll.:.~-:;-

4:..~~ a!!.-:-.:!....-:i.s:::~:.:.=:: c~ ar.e~-:..-:e~=.:: whi~~.~.ay _ !:a ~;7:.~~-= to. t.~e c:arat.:.cn.

c: :.:;e ~:::;-csa c: a::.*:a:-.c:..-.; ~ac..:..c::!.l a.~c sc:.~-::.:ic r_-:cr.-.rle~~, ! ~.ss.~'C t: t:;e a.::::-.:::-:i~:a c:==sa..:-/e::: :o t."":a c~ra~i::; r.:x:r.-

Ult~a:.;.ly - a!~a= -:::1 Ce:t..i.: c: ea:.?.ier, : e t!~ t:Sa!\\Jl l.i.!e of t.~e Z:clC"Z'.~~C?: is

~~..s, er i.::

and rot"..:...~~

e.~=;?:!cr-. i! i:. ~!.Ses t:, f*..:.":.c-...:i~ ef:~ively fer rcy ::-aciic::al I ~s-: :.::, have i: :-a.'TC'-'ec -

t."'.e pa~.::..t.:e: n-...:s:. ba rem::wec:

~ A.-:.c::J ~uclea:- Cc.t;:any or to i ~ cesi<<;"=".ee, (Cl.:...""'lic)

Accorc:i:-:gly, I a~ to c::n:.ac::

(Clir..ic) at :-eou.la: i."lte..""Vals o: no less t.~a.., t.--.ree r.cnt:."':.s c:u:lnq :.,e f i:s~ :r*ec c::!'tanc;e r.;* resice.~c:e.

C3...~ C."l r:':f pe!"SC:: c!..".C bracelet.

ar.c: ever., si." rront:.~ t.licreaf-:er a.".C h'he:ieve.r I

will aiways C'""'"::i' t.~e a;;:-t"O?riate ic:a!'l:i:iotiar.

will at all ti.":1!5 w-1a: t."':.e s~..?.-"""C ice."'1tification Kbedt:h.star.ci..~; ~ CC.""1tac:i."'1g t.":e i.'T?lan:i.~g clL"lic follo.-:ing t:J-.e i.-:.sertio:1 of a carciil: ?aC""'_....a!:.~:- of any ~er:, I ag=ee to rer."ain in pe_""icc:ic C'O:l:act \\*:it.'l rcy i:~:sc::al physician.

! wi 11 also i."'!Str..:c:-:: all ~..:ers of r::.1 housEl~old a.~ inio:::i t.~csa... ;no h.:iv~ <~:tc.r,ced cx:ntac:: \\dt.'1 rre that I have receivaci a rad.icisctc~ pa-:ercd,*."U:'C:.ia.c p.aC?r.i.:r-~lant.

I u.-..c:a:s':.a.":c:. :!-..it: :..":e rc1ciioiso1:--;::e ~

... -area cardiac: pa~.ar.er is an e..,-;::crir.:encal ~.,:. :.

..,, o:-:::::?: to.:ssass t.!-:e e:!ec-...:.*J\\?ness of t.~e c:evic::e, and to rrc.-iJ.~r rcy ?C=sa.al *..ell-being, (Clinic:)

is i.'"lte:es~ i.-: c:::l.:ec-....:..-:g ~t.1 t.:,-X-n t:..":a c:?Vl.Ci!.

Ac=:::.i.."iq.1.y, I agree to visit (Clinic) in ?!-""'SC:: er to t:"3.....smit.by t:ele?hc.~e (w1 :.-: :..-:e a.:.c. c: c1 cevic:? si...-;:pl.i.ed to rre anc: acel.::.ed to t.~e su=:a~ of ~ ski."i) ~ elec-_-:x:~-!.o==3ffl anc: an L~ic.at.:.=n of t.~e fu::c:-...:.:::.:.:-:; c: t:..":a f.:~'Tlc!.ker.

agree t:: pe..."'rni t t.~is n:::nit:::ti.-:c; to l::e

,e::-::::::: a:. leas-: ::::.:~ e*,;e:!* ~'::':?e :rc:-.-::.~s f:: t.-:e ~.: :s-:: ye~ a.-..C: eve...-y s i.:-: ~:.*.s t..":,arca:°-:.:?.!".

:*..:....-:.~e!" acr~ t===c'1"iC2 1..-:=:=:-:-.:: ::..:.c!"! e.-: r:::1 c.:..:..-.i:~l c--:..::.~::-: as i:. ?,::--:!L-.s t; t.~e ~~a..\\.:er a1: r:o less t..~-:. si.':

-:-.::::..-: i::.::::-:als.

*..:::..-:e_"':."C:a, I c=-~~,: ::: c!:.sc!cs.:-~ by :..-:a cli.-.ic c: a:.**-:- i:..:o~~-:.:..::: :.=-:r..:i:&:* !:.)' ~-:e c!..!..-:i: i..-"l =eqa:: :.:::: t..-:e :..~~a.~-:.a~icn c: :..~ =a:..:.::.s.:'::::.~ =~.. :er:': c:s.r.::.:..ac :acc.~.~ers: :=:vicsd, :°:C".*:a\\1e:, i.-: no e:-:.:a.~-:. s~:l.~ s*..;C:::: C..:.s=l:s*~es i:.c.!.1*-=e1 m~' !.c.:!.~~=-=.:.c:a.-:.:.~ t.. -i.:.-:.::-,.:~ =:*

.. ~......,_

a::.~*

cf **-s (Clir 52::..'.?s.

~ ~~,_.~ :-:.:~ -:..-.= =::=;-=:-:-:..:.-::-.=- ~:=.:.::: a.-.:* ~~s':.:.::-..s ;:.::-:..?.:...-..:...-:; ~ ~"u!

s...::;:.::il. :::====:.:::, -:..7-:9 :-::..=..:.:::...s:::;3 ?=:.::-:-:: c.::=.:..ac ;a:a.-:-.::.:-:e:, a.-:: t.~

-::.-::.!:.c::/ :c!:=.-:-*.::;: :=:::!c~::?. a:-.:: ~~.:?se cr~s-:ic~ t.:.*~*e l:::..-: a..-s:e~~

~= r::J* sa-:i.s:"a.c:.i:::.

7::!! pcssil:!e a!.~==:.a-.:.e ::-e-:.~c.c.s c: t.:a.:=.a::::.

i..-::l::=!..-:: t..~s csa c: c::.~~1:::~ic~a! ~e..'!'..i~l :a:.:.er.l :=e*.. *c::ec ;:ao.?--:ia::.ars,

~ave ~; cal!~ ~: =,;* at-:.a"!~~. a.,c: I l-:a::e =-~., ;.:.*:s.-: a.., c:-;or.:-.::-.i.t:-J to a.sk a.r:/ cr,:es:..:.:::-.s a.:-:.:-; t.~ese al ts.:::at::. "1! n-c:t.,ois.

t*li tl1 t.~:?se fac-~ L"'l. mi.'"lc: a.-:: wi t.'l t."!e i.-:.t.e."'lt. c! ;;;;L-:g legall~' CC".:::-.::,

release a-i-:1 :":.;-:":-: ~= c!.a.:..-: t.~at t.~e ill;:la."":':~::icr. c! a :-a=.ioisc-..c;e lX'--..C!rE ca:r...:i.:c :~~-:-t!.:.....:!~ *.-.*as ::c-: :==:=a:-ly au~'-.cri:~- a::C : a;=ae to t:.a £:-lla,.._u;

~=~=-=~~s a.-.: ~~e t.:::.:..~.::-::! r:?t::...~ of t.~e l.r:i: as c!.eo:a!.le-: a.::cve.

I as=ee

-::,1Sst=a t.~e :i!s~ ::: t..-:e i.~la.~-:atic:l of a =::diois:-::;:,e ?='**"e::C. ~a=e= a.-.:!

=::!.c~e a.~~ c:.:.sc.-::.=;:.l.. z:.c: :Xuc.!.i:;?.::, t.:*.e i:.;:la."?ti.~g c.!.i..-..ic er.: =: p:::;*sic:.m

===:-: fail'=3S r.c~ c=1.:Seti =: t.~ei: :'au.l.: or r:e;!iga."lce.

tiit.~ass (pre!e.:a::ly a rala:..::.ve)

Date Patie:1t' s sicn.at.u=e or t*JO pe.---sons a1.::.'iori:~ to c.:.-.sent for t.":e "fatient..

Fela:ic~!u.ps to t.'ic p.3ticnt:

si~ing i! other t..""..::: t?-.:: p:itlent.

Date Date I o:!rti!y t."'la.t: I l':a\\~ e:-;,lair.cc t.":e a.:ove proc:::-=ure:

C~NT'ZYTS or S?ONsoa*s PER10DIC R.f?ORT OH ct.L'UCA.I. P~UOR.".A.'fCt OF PACD'.\\JC.D.S (F.OR ~C:.!.\\.R ?AC~\\X.tlS A.'m CONV'ENT!ONAL ?AC~.AX.Z.t CCNTROU)

A.

For,;:a.c:e:.1iter, !:, !at!sfac:tot"T ser...,ic:e:

1.

~abula:e e.ach 1::plancec ~uclear and control pac:e::aker identl!

by serial or other a.ss!gned nw:ber.

For eac~ pac:e::.aker incl~

the f ::llc-Ji:g:

a.

ate of ::.anu:ac:ure

b.

ace of i:;,l...nc.

c:.

~dic:ate.-'het!ler :!xed rate or de::.and.

d.

A~e or pat1enc (at i::planc)

e.

rlant!~g i:sti:ut1on (can be coded).

f.

~ype of leads (=ake and :odel).

dic:ate bi-?olar. or unipolar.

h.

'ld!cate :::;*ocardial or e~docardial.

1.

,ace of lead 1=:,lant.

j.

u~ac!ou (in d.ys at c!:e of re,ort) of pace:.aker servic:

k.

ic:a:e t~e na:ure and data of any addi::o:al related si

!loc3t!or.s, or pose i:plan:ation cc:?licacions.

l.

~dic:ace vhec~a~ any lead -as re,laced, repaired, or rel, and daca(s) the~eof.~

m.

~ace of :ose recent follov-up e.~a=inacion.

u.

ndic:ace vhether patient vas carrying I.O. card and ~ear:

I.D. bracelet.

o.

!ndic:3:.e vnecher effecc1ve contac: '-3S being ~iatained vt:.h pac1.enc.

For oace:.a~e~s no lon2er satisfactorilv oacin~ t~e oatient:

1.

Tabu~a:a eac~ nuclear and control pace:.aker identi!ied by seri or ot~e: assi&":led nui::=er and i~clude the foll~*i~g:

a.

b.

c.

d.

e.

f.

g.

h.

J.

k.

ace of :.anufac:~re Date of 1:planc.

Indicate vhecher fixed race or de.::and.

Age of pacienc (at 1:planc).

!:;l.ant1.:g institution (cau be coded).

Type che leads (make and model).

Indicate bi-polar or unipolar.

!~dicace myocardial or endocardial.

Dace of lead 1::plant

Duration (in days) of satisfactory pace:.aker service befat re:oval or replacemenc.

For each re:::,ved or replaced pace.::aker or lead system, eXf in detail the reasons therefore and dace thereof.

not applicable for control patients ~"1th conventional pacemakers.

I I

I 1

I

I f I !

J I

k.

!n ~ase of deacn of the patient give:

dace and caus deach. autopsy findings relaced to the pacem.lker, de mination at autopsy (if possible) of whether pace:ak and lead system were still operable, pose-removal ev tion by spon*or of pace:i.aker and lead operability, a final disposition of pace::.aker.

C.

Accountaoilitv

1.

!!ave all i.::planted nuclear pace:akers been accounted for, reporting period? I! noc, explain in detail.

2.

Ras adequate follov-up contact vi.th any patient been lose the report!ng period? If yes, ext)lain in detail.

ARCO Pacemaker Annual Report February 12, 2019 ATTACHMENT B Copy of ARCO Authorization to Ship/Relinquishment of Ownership Form No pacemakers were shipped from Radiation Safety Associates, Inc. since the last report. The final pacer recovered from this program became available only recently. A report of its disposition will be made to ARCO and the U.S.N.R.C. in the near future.

11

ATTACHMENT C ARCO Pacemaker Annual Report February 12, 2019 Removal and Failure Rates for Nuclear Pacemakers 12

ARCO Pacemaker Annual Report February 12, 2019 ATTACHMENT C REMOVAL AND FAILURE RA TES FOR NUCLEAR PACEMAKERS A # Of Implants B

Of Removals C

Of Failures D Average Months of Service/Patient E

Percent Removals F

Percent Failures G Average Monthly Removal Rate H Average Monthly Failure Rate Calculations A=79 B = 78 C=26 From Table II (prev. yr.)

Current TOTAL SERV DAYS++

336,017 382 336,399 A (Service)++

B 10/15/80-1/25/18 PROGRAM TOT AL 79 79 79 79 26 26 200.03 206.75 98.73%

98.73%

32.9%

0.00718 0.00478 0.0024 0.0016 SERV IMPLANT TOTAL MONTHS++

DAYS*

MONTHS*

11,291.49 494,932 16,307.09 12.6 382 12.6 11,304.09 494,314 16,319.69 D= total program months

implants 15,815.12 = 200_19 and total months 15,802.52 = 200_03 79

implants 79 E = # ~emovals = 79 = 1.00 = lOO%

implants 79 F = #failures = 26 = 0.329 = 32.9% and

failures = 26 = 0.329 = 32.9%

implants 79

implants 79 G=

removals 79

= 0.00755 and

removals 79

= 0.00755

service months 10,460.86

program months 10,460.86 H=

failures 26 0.0024 and

failures 26

= 0.002485

service months 10,850.64

program months 10,460.86

+ Implant days were calculated from the date the pacemaker was implanted, until end of the reporting period.

++ Service days were calculated from 10/15/80, until the date the device was explanted.

13

ARCO Pacemaker Annual Report February 12, 2019 ATTACHMENT D PACEMAKER RELATED EXPLANTS The final pacemaker in the program explanted on February 11, 2019 upon the death of the subject. We do not have specific information regarding the patient's cause of death, but it is known that she had been in declining health for some time.

She passed away on Monday, February 11, at 0644.

14

X-1 X-2 X-3 X-4 X-5 X-6 X-7 X-8 X-9 X-10 X-11 X-12 X-13 X-14 X-15 X-16 X-17 X-18 X-19 X-20 X-21 X-22 X-23 X-24 X-25 X-26 X-27 ARCO Pacemaker Annual Report February 11, 2019 E

tdP xo an e k

acema ers Died, 1 January 1987. Pacer #107-NU-5F(A-102). Death not pacemaker related, but by renal failure and mitral valve disease.

Explanted 12 February 1987. Failure to capture-broken wire. Pacer #100-NU-5F(A-095),

implanted 4/9/73.

Died, 5/14/87. Not pacemaker related. Pacemaker #501-NU-5D(B-169). Implanted 4/17/78.

Explanted 5/22/87. Failure of sensing with occasional non-sensed beats and spikes in T-wave. Pacemaker #157-NU-5F(A-039). Implanted 11/23/73.

Explanted 6/12/87. Decrease in pulse rate. Pacemaker #549-NU-5D(B-200). Implanted 11/15/75 Explanted 5/15/87. Lead wire break. Pacemaker #492-NU-5D(B-159). Implanted 1/17/75.

Explanted 2/9/88. Pacemaker #128-NU-5F(A-060). Not pacemaker related & died of a myocardial infarction.

Pacemaker #3 l 8-NU-5F(B-004). Explanted 6/22/88. Pacer operating properly but patient needed a dual chamber device.

Pacemaker #97-NU-5F(A-064). Explanted 9/1/88. Upon implantation, pacemaker initially dropped then leveled off to 68 bpm. A recent bpm drop to 66 prompted Doctor to explant the pacemaker.

Explanted 9/20/88, Pacemaker #5 l 9-NU-5(B-156). Pacemaker malfunction; intermittent failure to sense.

Died, 9/30/88. Cardiac arrest. Pacemaker #474-NU-5D(B-124), implanted 11/23/73.

Explanted 11/16/88. Pacemaker #587-NU-5D(B-246). Pacemaker failure-failure to capture.

Pacemaker #592-NU-5D (B-251 ). Explanted on 12/28/88. Pacemaker was experiencing a "runaway phenomenon" (i.e., went up 150 born and then down to a very low born.).

Pacemaker explanted 10/08/88 due to sensing failure. Pacer #5 l 5-NU-50(B-l 54).

Pacemaker #l 75-NU-5F(A-067) was explanted August 1989 due to lead fracture.

Pacemaker returned 5/29/89 without any explant information. Pacer #NU5-074(A-042).

Pacemaker #363-NU-5F(A-048). Explanted 8-01-89. Patient experienced a decrease in pulse rate.

Pacemaker #476-NU-5(B-060). Explanted 11-29-89. Patient expired due to causes unrelated to the pacemaker.

Pacemaker #460-NU-5D(B-l l 7) explanted 04-13-90. Pacer functioning properly but a lead fracture prompted physician to implant a new pacer.

Pacemaker #70-NU-5F(A-027) explanted 07-09-90 due to lead fracture.

Died approximately 1/05/91. Cardiac arrest. Pacemaker #80-NU-5F(A-084), implanted 2-19-74.

Pacer #462-NU-5D(AN-l-55), implanted 3/3/75, was explanted on 01/25/91 due to a lead fracture.

Pacemaker #86-NU-5F(A-088) explanted 9/19/91. Hospital reprted sudden failure of pacemaker without additional detail.

Pacemaker #85-NU-5F(A-087) explanted 10/29/91. Pacemaker was removed due to end of pacemaker life parameter.

Pacemaker #362-NU-5F(B-046) explanted 12/3/91. Hospital reported that magnet reading started to decrease and pacemaker was running out of power.

Pacemaker #572-NU-5D(B-201) explanted on 1/7/92. Pacemaker was removed after patient died of congestive heart failure.

Pacemaker #083-NU-5(A-086) returned.

15

X-28 X-29 X-30 X-31 X-32 X-33 X-34 X-35 X-36 X-37 X-38 X-39 X-40 X-41 X-42 X-43 X-44 X-45 X-46 X-47 X-48 X-49 X-50 X-51 X-52 X-53 X-54 X-55 X-56 X-57 X-58 X-59 X-60 ARCO Pacemaker Annual Report February 11, 2019 Pacemaker #138-NU-5(A-078) returned.

Pacemaker #140-NU-5(A-026) returned.

Pacemaker #361-NU-5(B-044) returned.

Pacemaker #408-NU-5(B-069) returned.

Pacemaker #467-NU-5(8-121) returned.

Pacemaker #477-NU-5(B-138) returned.

Pacemaker #496-NU-5(B-161) returned.

Pacemaker #508-NU-5(B-062) returned.

Pacemaker #528-NU-5(B-213) returned.

Pacemaker #545-NU-5(8-196) returned.

Pacemaker #571-NU-5(B-l 70) returned.

Pacemaker #623-NU-5(8-290) returned.

Pacemaker #624-NU-5(B-271) returned.

Pacemaker #513-NU-5D(B-142) returned.

Pacemaker #465-NU-5D(B-065) was explanted on 28 July 1992. Pacemaker had reached its end of use parameter.

Pacemaker #532-NU-5D(B-083) explanted on 8/31/93. Hospital reported pacemaker was not operating properly. Pacemaker returned.

Pacemaker #131-NU-5F(A-100) explanted on 9/19/93. Cause of death was renal failure, not related to pacemaker. Pacemaker returned.

Pacemaker #NU5-499 was returned on 6 March, 1998 Pacemaker #NU5-103 explanted on 5/27/98. The pacemaker was removed because the lead was broken. Pacemaker returned.

Pacemaker #NU-509 explanted on 12 June, 1998. Cause of death was renal failure, not related to pacemaker.

Died, 9/16/87. Not pacemaker related. Cardiac arrest. Pace #342-NU-5F (B-016),

implanted 10/8/74. Pacemaker not retrieved.

Explanted 10.2.87. Not sensing patient's own beats and firing on T-waves, causing ventricular tachycardia. Pacemaker #144-NU-5F(A-091). Implanted 7/27/73. Pacemaker not retrieved.

Died 8/01/89. Pacemaker 115-NU-5F(A-109) not retrieved from Elmhurst General Hospital. Cause of death uncertain.

Pacemaker #145-NU-5(A-093) buried with patient.

Pacemaker #535-NU-5(8-179) buried with patient.

Pacemaker #583-NU-5(B-240) not returned by funeral home.

Pacemaker #581-NU-5D(B-237) explanted on 5 December 1994. No reason was given for removal. Pacemaker returned.

Pacemaker #155-NU-5F(A-031) explanted on 24 October 1994. Pacemaker was working fine, but doctor recommended a different type. Pacemaker returned.

Pacemaker #341-NU-5F(B-002) explanted on 17 March 1995 for an un!!faded pacemaker.

Pacemaker #542-NU-5D(B 189) explanted on 20 April 1995. Cause of death uncertain.

Pacemaker #525-NU-5D (B-190) explanted on 19 September 1995 Surgeon said pacemaker was failing and there was an infection in area of the pacemaker. Pacemaker returned.

Pacemaker #61 l-NU-5D(B-269) explanted on 23 August 1996.Patient died in her sleep and cause of death is unknown. Pacemaker returned.

Pacemaker #537-NU-5D(B-184) explanted on 4 June 1997. Cardiologist said removal was for **end oflife pacemaker."

16

X-61 X-62 X-63 X-64 X-65 X-66 X-67 X-68 X-69 X-70 X-71 X-72 X-73 X-74 X-75 X-76 ARCO Pacemaker Annual Report February 12, 2019 Pacemaker# 126-NU-SF(A-028) was explanted from patient by a physician who indicated the unit was removed due to the end of the pacemaker life parameter.

Pacemaker #NU-SD-481 was explanted from patient by an undertaker on 22 February 1999. The pacemaker was removed upon patient's death. The cause of death is unknown.

Pacemaker #506-NU-SD was explanted on 14 December 1999, as reported by the NJ Pacemaker and Defibrillator Evaluation Center. The pacemaker was removed due to a fluctuation in the rate.

Pacemaker #504-NU-SD(B-174) explanted on 10/11/00. Pacemaker explanted due to patient disease. Pacemaker working fine according to Dr. 's office.

Pacemaker #523-NU-SD B-172 explanted on February 6, 2002 at New Jersey Pacemaker and Defibrillator Center, Newark, NJ. Pacemaker returned.

Pacemaker #498-NU-SD B-162. Patient died May 8, 2002, pacemaker explanted on that date. Pacemaker returned.

Pacemaker #481-NU-SD, explanted October 8, 2002. Device reached recommended replacement time. Pacemaker returned.

Pacemaker# 490-NU-SD B-157, explanted August 18, 2003. Device reached recommended replacement time. Pacemaker returned.

Pacemaker# 459-NU-SD, B-113. She passed away on November 12, 2004 while confined to a nursing home. The funeral director recovered the pacemaker and returned it to ARCO.

Pacemaker #529-NU-SD, 529-NU-SD, explanted in 2004 and returned to Los Alamos by the hospital.

Pacemaker# 527-NU-SD, B-211. Pacemaker was not functioning when it was checked in November 2004. It was returned to ARCO.

Pacemaker# 562-NU-SD, B-183. Pacemaker stopped functioning ands was replaced in May 2005. It was returned to ARCO.

Pacemaker #539-NU-SD was explanted August 18, 2006 and was returned to NSSI/LANL by the hospital.

Pacemaker #544-NU-SD was explanted a few days after the death of the patient on June 19, 2008. It was returned to NSSI/LANL by the pacemaker clinic in New Jersey.

Pacemaker #090-NU-SF (A-092) was explanted on April 15, 2014. It was retrieved from the Newark Beth Israel Pacemaker Center and is in safe storage in Hebron, CT.

Pacemaker #094-NU-SF. Patient expired on 2/11/19. Pacemaker was recovered by Jackson Memorial Hospital staff and is in safe storage. It will be transferred to Radiation Safety Associates, Inc., Hebron, CT within 6 weeks 17

NR-1 NR-2 NR-3 NR-4 NR-5 NR-6 U-1 U-2 Explanted Pacemakers Not Retrieved ARCO Pacemaker Annual Report February 12, 2019 Died 8/01/89. Pacemaker 115-NU-5F(A-I09) not retrieved from Elmhurst General Hospital.

Cause of death uncertain.

Pacemaker #145-NU-5(A-093) buried with patient.

Pacemaker #535-NU-5(B-179) buried with patient.

Pacemaker #583-NU-5(B-240) not returned by funeral home.

Pacemaker #524-NU-5D(B-185) buried with patient. Cause of death unknown. Died on 11/20/94 Pacemaker #149-NU-5F(A-063) buried with patient. Cause of death unknown. Died on May 10, 1998.

Pacemakers Whereabouts Unknown 18

NRC FORM 532 U.S. NUCLEAR REGULATORY COMMISSION (05-2016) *¥'

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ACKNOWLEDGEMENT - RECEIPT OF CORRESPONDENCE

~ *

, II:

0

~i--,

.0, Name and Address of Applicant and/or Licensee Date I

April 10, 2019 I

ARCO Environmental Remediation, LLC License Number{s)

I SNM-1993 I

ATTN: Cynthia D. Kezos, Liability Business Manager Mail Control Number(s) c/o Atlantic Richfield Company I

611852 I

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[Z] There were no administrative omissions identified during our initial review.

D This is to acknowledge receipt of your application for renewal of the material(s) license identified above. Your application is deemed timely filed, and accordingly, the license will not expire until final action has been taken by this office.

D Your application for a new NRC license did not include your taxpayer identification number. Please complete and submit NRC Form 531, Request for Taxpayer Identification Number, located at the following link:

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Your application has been assigned the above listed MAIL CONTROL NUMBER. When calling to inquire about this action, please refer to this control number. Your application has been forwarded to a technical reviewer. Please note that the technical review, which is normally completed within 180 days for a renewal application (90 days for all other requests}, may identify additional omissions or require additional information. If you have any questions concerning the processing of your application, our contact information is listed below:

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