ML20195C751
| ML20195C751 | |
| Person / Time | |
|---|---|
| Site: | 07001331 |
| Issue date: | 04/30/1999 |
| From: | Michelle Beardsley NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20137S704 | List: |
| References | |
| 126508, NUDOCS 9906080289 | |
| Download: ML20195C751 (24) | |
Text
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u.s. NUCLEAR REGULATORY CoMMisslON Amundm:nt No.12 MATERIALS LICENSE ucensee
- 1. Veterans Administration Medical Center 3. ucense number SNM-1305 g gR F Eqg
- 2. 3495 Bailey Avenue b 4. Expiration due Not Applicable Buffalo, New York 14215 h 5. Docket No. 070g331 Reference No. p i lu - G% O A
- h .#, h in cecordance with the lette sted January 2551999dhis icense
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reby term nated.
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$7 For the U.S. Nuclear Regulatory Commission ,
l Original signed by Michelle Beardsley D:t3 - Anril 30.1999 By Michelle Beardsley j Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety Region I i gg, , King of Prussia, Pennsylvania 19406 PDR ADOCK 07001331 ,
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OFFICIAL RECORD COPY ML10 {
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April 30,1999 Docket No. 070-01331 License No. SNM-1305 Control No. 126508 William F. Feeley Director Veterans Administration Medical Center 3495 Bailey Avenue Buffalo, NY 14215
Dear Mr. Feeley:
Please find enclosed Amendment No.12 terminating License No. SNM-1305 as requested by yourletter dated January 25,1999.
Your cooperation with us is appreciated.
Sincerely, Original signed by Michelle Beanisley l Michelle Beardsley Health Physicist Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety
Enclosure:
l Amendment No.12 cc:
Jayakumari M. Gona, M.D., Radiation Safety Officer E. Lynn McGuire, Director, National Health Physics Program I
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l DOCUMENT NAME: B:\DNMS Documents \Lic Cover Letter \LSNM-1305.wpd 87343416 To receive a cap ' of this document, Indicate in the bar: *C's Copy we attach /enci *E's Copy w/ attach /end v = No copy OFFICE DNMS/Rl n lN DNMS/RI l l -l NAME MBeardsleynt7 DATE 04/30/99 il 04/ 199 04/ /99 04/ /99 OFFICIAL RECORD COPY l i
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O O Materials License Terrnination/ Retirement Fcnn LICENSE #(s): NNM' / 3dI DOCKET #(s): d ~1d - 6 / 3 3 /
, EXPIRATION DATE: ww /03/
ADDRESS: 1/4 Mb a'- CN-ay 9 P tu // eu /&c . DATE OF CONTACT: W/
- s/4/o /N // v 2 i r CONTACTED BY:
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TITLE:
TF1EPHONE:
LICENSETERMINATED1 LICENSETRANSFERRED:
LICENSETRANSFERRED TO: Name:
Address:
TW-BASIS FORTERMINATION AND/ORRETIREhENT:
Du ou tr>,a /er5 fv 4 W A 2 i n k rnerf A.
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/1 TERMINATION DOCUMENTATION
- 1. License termination meets Type I criteria: Y _ N ._.
_._ L*-- used sealed somces only and the most recent leak test demonstrates that they did not leek while in the licensee's possession
,__ Haanaaa used radioactive material with Tm $ 60 days and it has decayed to less than the activity in 10 CFRPart20 AWN C
- 2. License termination meets Type II criteria:
Y.__N _
l
__ Licensee possessed and used only sealed sources but cannot demonstrate that the sources did not leak while in the liaanmaa's possession
._ Licensee possessed unsealed radioactive material with Tm 560 days but the maximum activity authorized under the license has not decayed to less than the quantity specified in 10 CFR;M 20, Appendix C -
_ Licensee p=aaaaart unnaaled radioactive material with Tm > 60 days but 5120 days.
_._ Lirannaa possessed 't or 'H but the total activity (s) and use authorized under the license warrants decomminaioning under Type II (describe rationale above) l l
Rev.O, December 1996 F-1 NUREG/BR-0241 126508 0FFIC!ALRE00RD00PY . ML10 m
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- 3. License termination meets Type III criteria: Y_N _
__ Decommissioning quali6es for a categorical exclusion under 10 CFR 5l.22 (c) and
_ Licensee will d=-= -ission its facility in acccadi.c.cc with the NRC's criteria for unrestricted use.
- 4. License termination meets Type IV criteria: Y_N_
__. D-missioning does not qualify for a categorical exclusion under 10 CFR 51.22 (c)
__ Licensee will hmission its facility such that residual radioactive material may remain in excess of NRCs criteria for unrestricted use.
- 5. Termination survey required: Y_N_
_ Termination survey submitted by licensee
__ Terrnination survey satisfies NRC survey requirements
- 6. Form 314 or equivalent submitted: Y h N _._
Staff verified disposition of sealed souw g /j or unsealed radioactive material by:
$ letter from Form 314 recipient
_ callto Form 314 recipient
- 7. Licensee transfer records di_eM in 10 CFR Parts 30.35,30.36, 30.51 ; 40.36, 40.42, 40.61; or 70.25, 70.38, 70.51 Y_N_
__ To USNRC
__ To individual assuming responsibility for the license, with a copy of the cover letter to NRC
- 8. NRC closeoutiaWon required: Y _ N ._.
__ Closeout inspection performed:
on:
Tawar:
- 9. Closeout survey performed: Y __ N __
on:
by:
Licensing assistant completing form: Date:
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Branch Chief: Date: )
NUREG/BR-0241 F-2 Rev. O, December 1996 6 6 :. i L a
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l0.102 P.2 O O c76-6/331 DEPARTMENT OF VETERANS AFFAIRS "O Medical Center dI l l 3495 Bailey Avenue Suffalo NY 14215 Apn123,1999 in R@ Rdc To:
ll4 United States Nuclear Regulatory Commission Region 1 475 Allendale Road King of Pnissia, PA 19406 Attn. Ms. M. Beardsicy Regarding NRC License # SNM-1305 ControlNumber: 126508 l
Ms. Beardsley:
This correspondence is in response to your letter dated March 18,1999. Attachedyou willDnd copics of conespondence from Coratomic, which is now Biocontrol Technology, and Medtronic regarding the disposition of the nuclear powered pa~=4~s.
'Ihe corrceywss;c from Biocontrol Technology, dated April 7,1995, indicates that all pacenakers, implanted at this facility, have been retmned to dat company.
Several correspondence from Medtronic are attached and they include the following information-
- 1) Dated May 18,1995 - This sunuunnzed the then current status of all Mcatronic pacemakers that been huplanted at this facility. All devices were indicated as lutving been renirned except tbr four pacemakers Of those four, the first was being followed at the VA Medical Center at Little Rodc, Arkansas, with whom we had set up an infonnaion sharing agreement regarding office visits, contact with the patient, etc.... That device was returned to Medtronic as indicated below (#2).
The second device was being added to the NRC bcense for the VA Medical Center at New Orleans,1misiana as indicated below (#3). The third device was being follouw! at this Medical Center and it was returned to Medtronic in May of 1996 as indicated below (#4). The fourth,and final, dwice is most certainly buried in Fon Logan Cemetery in Colorado as was comamnicated to your oob on June 22,1995 and Mardi 8,1999.
- 2) Dated November 18,1998 - Cotrespondena frorn Medtronic confirtmng receipt of Little Rode VA pacemaker.
- 3) Dated June 5,1995 - Corra===t*~= fmm New Orleans VA Medical Center director regardung the addiaan and trackmg of the formcr Buffalo VA pacemaker patient by that (New Oricans) NRC licensee.
- 4) Dated April 28,1999 - C=.nyvi&w from Medtronic confirming receipt of the Buffalo VA pr6A on May 14,1996.
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@R.EU.1999 ~ 1856PM i10.402 P.3 O ,O P$ ease contact Mr. Philip Cenaiaba Radiation Safety OMccr, at (716) 834-9200 cxtension 5226 if you
.- have any questions or reqmre additional infonnation. Thank yoa.
.M
' WILLIAMF.FEELEY Director, VA WestemNew York Healthcare System Attachments:(6) i j
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l 3ax Transmission No. of pages incl. this one: 1 To: Phillip Cunningham Fax number: 718-862-3411 From: Marilyn Hawley Date: Friday, April 7,1995 If you do not receive all pages, please contact:
Biocontrol Technology 300 Indian Springs Road Indiana, PA 15701 412-349-9147/412-349-9458
Subject:
Pacemakers SpecialInstructions:
- Cur r-: cords show all the pMemakem you asked me about were explanted. Implanted Explanted
-- 7 C C-100, S.N.143 7-30-75 9-26-75 Replaced C-101. S.N. 004 9-26-75 2-11-92 C-100, S.N.144 8-6-75 3-25-81 Replaced Unknown C-100. S.N.149 8-21-75 9-10-75 Repicaced C-101, S.N. 010 9-10-75 3-30-81 C-101, S.N.185 12-1-76 11-4-93 For yourinformation all pacemakers have returned to Coratomic which is now Blocontrol Technology.
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APR. 1999 1:57PM IU 402 P.5 g
U v M*aw iac-NiedtronicB 7000 Cen*ral Avenue, N.E.
Minneapolis. MN 55432 3576
' Telephone:(612) 574 4000 Cable; Medtronic Telex: 29-0598 i
May 18, 1995 Mr. Philip Cunningham Radiation Safety Officer DVAMC 3495 Bailey Avenue Duffalo, NY 14215 Re: Your. letter of May 16, 1995, " Final status report on device j~ dispocitions (Nuclear Pacemaker)
Following is the latest status we have regarding the noted Model l
9000 pacemakers.
-I RBHE SERIAT,e DEVICE STATUS
_1 2R00035 Returned to Medtronic 1/22/92 2R00037 Returned to Modtronio 12/12/94 2R00009 Lost, last follow-up 8/7/83 M *6 __" **'Q, 2R00065 Lost, last follow-up 9/27/09 c ena.c stace I 2R00096 Returned to Medtronic 6/17/87 l 2R00043 Returned to Medtronic 1/3/77 2R00108 Returned to Medtronic 4/27/83 2R00106 Returned to Medtronic 2/22/82 2R00131 Returned to Medtronic 11/23/76 l 2R00193 Returned to Medtronic 9/8/81 3R00016 Returned to Modtronic 9/8/80 3R00009 Returned to Medtronic 11/4/86 Q 3R00008 Lost, last follow-up 3/18/92 New o'l W 5 3R00012 Returned to Medtronic 10/18/89 3R00018 Returned to Medtronic 3/20/78 3R00005 Returned to Medtronic 6/8/94 I 3R00028 Returned to Medtronic 4/18/95 I 3R00019 Returned to Medtronic 9/1/89 Page 1 of 2.
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'* MR. ,,1999
- J:57PM D 10.402 P6 d \_/
I I HARE SERIAL DEVICE _ STATUS 3R00020 Lost, last follow-up 4/29/92 Law 3R00324 Returned to Medtronic'8/12/94 4R00262 Returned to Medtronic 1/20/83 4R00267 Returned to Medtronic 7/16/79 4R00315 Returned to Medtronic 11/29/78 4R00370 Returned to Medtronic 9/1/83
+ SR00008 Returned to Medtronic 7/25/77 SR00018 Returned to Medtronic 7/25/78 W #
If you require additional information please feel froo to contact i tno in the future.
Sincerely, MEDTRONIC, I .
5,Q.
Larry A. Paulson, P.E.
Post Market Surveillance Manager Clinical Operations i
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Page 2 of 2.
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Medtronic, Inc.
l 7000 Central Avenue N.E.
Minneapolis, MN 55432-3576 ll l -
Telephone:(612) 574-4000 Cable: Medtronic i
! Telex: 29-0598 November 18,1998 Phil Cunningham DVAMC 3495 Bailey Avenue
'} Duffalo, NY 14215 t
RE: Our telecon today, j
Dear Mr. Cunningham:
This letter is to confirm that a mode 19000 nuclear pacemaker, S/N 2R00065, was received by Medtronic from the VA Medical Center in Little Rock, AR on 16 November,1998, if you require additional inforrnation, please feel free to contact me at 1-(800)-328 2518, ext. 6232.
l Sincerely,
, MEDTRONIC, INC.
/ as .
Larry A. P'aulson, P.E.
Chronic 1.nad Study Monitor Drady Clinical Operations i
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DEPARIMENTOF VETERANS AFFAIRS MedicalCenter 1601 Perdido Street New Orleans 1.A 70146 JUN - 51995 ,
in ne 629/001S S S # ply Refer To:263-28-4224 j j
BROWN, Stacy i
Richard S. Droske i Medical Conter Director !
DepartEent of Veterans Affairs !
Medical center (528/112) 1495 Bailey Avenue niif falo, NY 14215
Dear Sif:
This is espdnse to your letter of May 12, 1995 regarding acility in ne ho had a nuclear pacomaker implanted at your 1973.
Our Radiation Safety Officer, Mr. Carl Gaspard, telephoned Ms.
letter.
Suzanne Michalok on Wednesday, May 24, 1995 regarding your Ms. Michalek referred him to your Radiation Safety' officer, Mr. Phil Cunningham. Jr. Caspard informed Mr. ,
Cunningham that[ fis currently being followed at !'
this Medical Center in the Cardiology Clinic. He was acen in the .
clinic on May 5, 1995. A copy of the Doctor's Progress Notes is enclosed for your information.
- An application was filed with the NRC on July 13, 1994 for
- renewal of our Nuclear Powered Pacemaker License. Doctors Michael Ian Prior and Salem F. Sayegh are listed under the license as the physicians r ponsiblo fo d ollow-up of the nuclear pacemaker patients, the patients to be follevnd. i: was listed as one of 1 A Report of Contact, will be provided to you by Mr. Cunningham. relative to the telephone conversatio Officer, If you Mr.have Carl any questions, L. Gaspard, at please call the Radiation Safety *
(504) 589-5910.
Sincerely yours, i N John D. Chur , Jr.
}MedicalCenterDirector 3 Enclosure
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, Apr 99 10:0BAM; Page ?/2 00 N Modtronic, Inc.
7000 Central Avenue N.E.
Minneapons, MN 55432-3576 Telephone: (612) 574-4000 Cable: Medtron'ce Telex; 290598 April 1 5,1999 Phil C nningham, Radiation Safety Officer DVAM3 3495I miley Avenue Buffakl, NY 14215 RE.d sTelecon today, l
Dearh r. Cunningham-This le 14, 191 8. ter is to confkm that Modtro* receNed a Model 9000 nuclear pecemaker, S/N 3R00020, If you i equire addifjonal informaton, please fel inse to contact me at 1-800 326-2515, ext. 6232.
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MEbTljoNIC,INC.
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Post Mlitteet Surveittance Manager Brady Clinical Opemtions (l
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March 18,1999 I Docket No. 070-01331 License No. SNM-1305 Control No. 126508 I
William F. Feeley Director Department of Veterans Affairs Medical Center 3495 Bailey Avenue Buffalo, NY 14215
Dear Mr. Feeley:
This is in reference to your letters dated January 25 and March 8,1999 requesting to terminate Nuclear Regulatory Commission License No. SNM-1305. In order to continue our review, we need the following additional information:
Please send documentation (i.e. copies of shipping papers or letters) from Medtronic and Coratomic confirming their receipt of the pacemakers currently listed on your license.
We will continue our review upon receipt of this information. Please reply in duplicate to my attention at the Region i Office and refer to Mail Control No.126508. If you have any technical questions regarding this deficiency letter, please call me at (610) 337-6942.
If we do not receive a reply from you within 30 calendar days from the date of this letter, we shall assume that you do not wish to pursue your application. !
Sincerely, l
Original signed by Michelle Beardsley .
l Michelle Beardsley Health Physicist Nuclear Materials Safety Branch 1 l Division of Nuclear Materials Safety
Enclosure:
10 CFR Pads 19,20, and 30 i'
cc:
Jayakumari M. Gona, M.D., Radiation Safety Officer Philip Cunningham ML10 .
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, W. Feeley . 2 Department of Veterans Affairs Medical Center I
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l DOCUMENT NAME: B:\DNMS Documents \Def LetteALSNM-1305.wpd 83061346 :
To receive e cop ' of this document, Indicato in the trom:"C" a Copy w/o attach /enci "E's Copy wf attachtenci "N a No copy OFFICE DNMS/RI s G lN DNMS/RI . l l l NAME MBeardsley \\R7 U
DATE 03/18/99 03/ /99 03/ /99 03/ /99 OFFICIAL RECORD COPY i
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O O DEPARTMENTOFVETERANS AFFAIRS Nh Medical Center 3495 Bailey Avenue n%
J Buffalo NY 14215 March 8,1999 in Rep?y Refer To: II4 United States Nuclear Regulatory Commission Region I 475 Allendale Road King of Prussia, PA 19406 Atta. Ms. M. Beardsley Regarding: NRC License # SNM-1305 Control Number: 126508 Ms. Beardsley:
This correspondence is in response to your comersation of March 1,1999, with our Radiation Safety Officer, Mr. Philip Cunningham, conccming our request to terminate Pacemaker License #SNM-1305. For your reference, you will find attached a copy of a letter from this facility to the Nuclear Regulatory Commission dated June 22,1995, which summarized the then current status of all licensed desices.
As outlined in the above nentioned letter, all devices manufactured by Arco, Inc. and Coratomic, Inc. had been returned to the manufacturer. Of the twenty six desices manufactured by Mcdtronic, Inc., twenty two had been returned to the manufacturer, one was being followed locally, one was being followed through a sharing agreenent with the VA Medical Center in Little Rock, Arkansas, one was being followed by the VA Medical Center in New Orleans, Louisiana, and one was most probably buried in Fort Logan Cemetery in Demer, Colorado.
11e device being followed locally wras explanted and returned to Medtronic on March 25,1996. The device being followed at the VA in New Orleans, which had been added to their NRC license, was explanted and returned to Mcdtronic on March 29,1996 (see attached copy ofletter to NRC Region IV).
Tie unit being followed via the sharing agreement with the VA in Little Rock was explanted and returned to Medtronic on November 10,1998. -
Tie final Coratomic, Inc. pacemaker, which was listed on our license, was explanted and returned to Coratomic on November 4,1993.
Picase contact Mr. Philip Cunningham at (716) 834-9200 Extension 3108 ifyou have any questions or require additional information. Thank you.
h -
WILLIAM F. FEELEY Director, VA Western w York Healthcare System Attaciunents:(5)
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MAR l 2 SEE OFFICIAL.RECORDCOPY ML10 l
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o, DEPARTMENTOFVETERANS AFFAIRS _
Medical Center 3495 Bailey Avenue Butfalo NY 14215 in Reply Refer To:
United States Nuclear Regulatory Commission Region I 475 Allendale Road King of Prussia, PA 19406' Atta.: Mr. James Dwyer RE: NRC License # SNM 1305 i
! l Mr. Dwyer; f
l As was communicated to your ofr.cc on June 6,1995, this facility has completed it's inquiry into the status of all nuclear powered cardiac pacemakers ever implanted at tids Medical Center. The results of I that inquiry are given below:
l' e
Background:
From September of 1973 to December of 1976, forty (40) nuclear powered cardiac pacemakers were I implanted in humans subjects at this Medical Center. Those pacemakers were supplied by three (3) different manufacturers and the current disposition of each device is broken down below by manufacturer.
- 1) Manufacturer: ARCO,Inc.
PacemakerModel: ARCONUS Number of Devices Implanted: ten (10)
Implantation Date's: September 1973 to December 1975 Status of Devices: All devices returned to manufacturer
- 2) Manufacturer: Coratonde,Inc.
Pacemaker Model: C-100 and C-101 Number of Devices Implanted: four (4)
Implantation Dates: August 1975 to December 1976 Status of Devices: All devices returned to manufacturer J
- 3) Manufacturer: Medtronic,Inc. ,
Pacemaker Model: Laurens-Alcatel Model 9000 Number of Desices Implanted; twenty six (26) implantation Dates: July 1972 to September 1975 Status of Devices:
. A) Twenty two (22) have been returned to the manufacturer.
B) One (1) device is being followed locally.
J
C) One (1) device is being follourd at the Department of Veteran's Affairs Medical Center (DVAMC) in Little Rock, Arkansas. An information sharing agreement has been set up between the Buffalo and Little Rock DVAMC's to fulfill the requirements of following this device as outlined in our NRC License.
D) One (1) device is being followed at the DVAMC in New Orleans, Louisiana. That device is currently followed by a NRC license issued to that DVAMC.
E) The individu 1 containing the last device died in Denver, Colorado on We have obtained a copy of this man's death certificate and
{that record c indi'ates that this individual died of natural c Central llospital and was buried at Fort legan National Cemetery in Denver, Colorado. A member of the staff of the funeral home, at which this man was handled , reviewed all available records at the funeral home and she stated that no mention was ever made of a pacemaker being removed or handled. A search for records at St. Anthony Central Hospital indicated that the man's medical records have been destroyed. While interviewing this patient's physician, who is the same individual who signed tids man's death certificate in Denver, we learned that because the man died of natural causes (cardiac arrest, due to or as a consequence of congestive heart failure, due to or as a consequence of coronary disease) an autopsy would not have been performed.
The pacemaker manufacturer has stated that they have not received this device.
We believe that it is very possible that the device in question is buried at Fort legan National Cemetery. The identification of the patient and the precise location ofIds burial is given on Attachment #1.
==
Conclusion:==
Besides the one device, which is possibly in Denver, Colorado, all of,the nuc! car powered cardiac pacemakers ever implanted at this facility have been returned to the manufacturers or they are being followed as specified in our Pacemaker License.
During the mid and late 1970's and early 1980's, pacemaker patients who had devices implanted at this facility routinely left the area to live in other parts of the country. Tids facility failed to either continue to track them or to ensure that those individuals were picked up by another facility widch was appropriately licensed by the NRC. When a patient left the Buffalo area, our records usually indicated a facility, generally a DVAMC, to which the patients were supposed to be reporting. Unfortunately, that was as far as tids facilities' tracking of patients went. Clearly, we were in violation of numerous license conditions including condition numbers 13,14,15,16, and 17, and we failed to ensure that the facility to widch a patient had transferred to had obtained an appropriate NRC License or that an information sharing agreement had been set up to maintain compliance with applicable license conditions.
Before initiating tids investigation, tids facilities' current Radiation Safety / Health Physics Staff was under the impression that we were in compliance with all NRC license conditions based on the results of the last few NRC inspections of tids license. We regret the obvious lack of mersight which existed in the 1970's and early 1980's conceming our pacemaker license and we feel our current Radiation Safety Staff is capable of prmiding excellent oversight of our Radiation Safety Program, as evident by the self identification of the problems associated with the past management of the Pacemaker license.
If necessary, please contact Mr. Philip Cunningham at (716)834-9200 Ext. 3108 or Dr. Jayakumari Gona at (716)834-9200 Ext. 3635 concerning this issue. Thank you.
Sincerely, g .s
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- Richard S. Droske Medical Center Director i Attachinents: (1)
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1 Attachment 1 - NRC License # SNM-1305 06/22/95 1
Patient Narne:
7 i l Patient SSN:
Date of Death: )
Physician who Signed Death Certificate: RD. Spangler, M.D.
4200 W. Conejos Place Denver, Colorado 80204 Funeralllome which Handled Deceased Individual: McConaty's Blvd. Mortuary 3020 Federal Blvd.
Denver, Colorado 80211 l
Location of Burial: Fort Logan National Cemetery l 3698 S. Sheridan Blvd.
Denver, CO 80235 i A l W
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O DEPARTMENTOF VETERANS AFFAIRS .
Medical Center \
1901 Perdido Street 3 New Orleans LA 70146 ,
1 in Reply Refer To:
629/EOWSM Vivian H. Campbell U. S. Nuclear Regulatory commission Nuclear Material Licensing Section Region IV 611 Ryan Plaza Drive, Suite 1000 Arlington, TX 76011 4 Dear Ms. Campbell As per telephone conversation with Mr. Carl Gaspard on 4/1/96, this is to inform you that one of the Plutonium-238 '
nuclear-powered pacemaker patients, listed on NRC License No.
SN
{ M-1 36, expired on C ~ and his pacemaker was removed on Informatierrpertai]ning to the pacemaker is as follows:
Patient: --
Social security Numbers /
Pacemaker /Model/f_N:
Date of Implant:( MeditTonics Model F60~0,(.
] }.
by Medtronics, Inc.On the afternoon of 3/29/96, the shipping carton, furnished Wipe tests were Scintillation coun,ted counter using the Packard Tri-Carb Liquidwas receive 4530, #34620.
microcuries of removable contamination (Enclosure 1).Results we Enclosed is a list of the pacemaker patients who either have expired or have had their pacemaker explanted / replaced (Enclosure
- 2) and the current nuclear pacemaker patient (Enclosure 3).
If you should have any questions, please contact the Radiation 589-5910. Safety Officer, Mr. carl L.-Gaspard, at (504)
Sincerely yours, John D. church, Jr.
Medical Center Director Enclosures 3 cc:
Program Director, VAMC, Ann Arbour, MI (111E)
Southern Regional Director, Jackson, MS (133)
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O O U. S. Nuclear Regulatory Commission Date:3-1-99 Telephone or Verbal Conversation Record Time 10:30 a.m.
Incoming Call _x_. Outgoing Call _ Visit Person Calling: /j Office: USNRC Region l Phone #:(610) 337-6942 Michelle Beardsley r Person Called: Office: Phone #:
Phil Cunningham, RSO Conversation
Subject:
VA Buffalo, NY License No.SNM-1305 Docket No.070-01331 Control No.126508 Summary:Regarding their request to terminate the above license, I requested the following additional info.:
Please specify the disposition of EACH pacemaker currently listed on their license, l.a. returned to manufacturer, transferred to another licensee; if transferred please specify the licensee's name and their acknowledgement of follow-up.
Referred to:
Action Requested: Submit additonal info.
Action Taken:
OfFICIALPIC0iiDCOPY ML10
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This is to acknowledge the receipt of your letter / application dated
/ , and to inform you that the initial processing which includes an administrative review has been performed. _;
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There were no administrative omissions. Your application was assigned to a i technical reviewer. Please note that the technical review may identify additional !
omissions or require additional information.
l Please provide to this office within 30 days of your receipt of this card !
,j A copy of your action has been forwarded to our License Fee & Accounts l
j Receivable Branch, who will contact you separately if there is a fee issue involved.
Your action has been assigned Mail Control Number 12650,8
-! When calling to inquire about this action, please refer to this control number.
You may call us on (610) 337-5398, or 337-5260. j l maceanu su mi Sincerely, s om Licensing Assistance Team Leader i
.+
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a- DEPARTMENT OF VETERANS AFFAIRS o
Medical Center 3495 Bailey Avenue Buffalo NY 14215 in Reply Refer To:
l January 25,1999 p14 ' g/7N I U.S. Nuclear Regulatory Commission 475 Allendale Road King of Prussia, PA 19406 :
Attn. Mohammed M. Shanbaky, Ph.D., Chief, Nuclear Materials Safety Branch i
Subject:
Initiation of Decommissioning ProcessfTermination of NRC Nuclear Pacem=Ler License # SNM 1305 Dr,Shanbaky, I
We hereby request tennination of our NRC Nuclear Pacemaker License # 1305. All implanted devices {
have been returned to their manufacturers or are being followed by other licensees with pacemaker 1 licenses.
From September 1973 to December 1976, fony (40) nuclear powered nace==ke's were implanted in human subjects at this Medical Center. Since that time we have been trackmg those patients, as required by our license, and returning devices to the appropnate manufacturers as the pacemakers have been explanted. ;
Please contact Mr. Philip Cunningham, Radiation Safety Officer, at (716) 834-9200 Extension 3108 if your office requires any additional information or actions regarding this matter. Thank you. ,j WILLIAM F. FEELEY l Director, VAWNYHCS I 126508 OFFICIAL.RECORDCOPY ML 10
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,4 [~T : (']FOR LFMS USE)
\- : IN~aRMATION FROM LTS DETWEENs' : --------------------
License Fee Management Branch, ARM : Program Code: 22160 and : Status Code O R;gional Licensing Sections : Fee Category: EX 7C
- Exp. Date: 20021031
- Fee Comments: PACEMAKER
- Decom Fin Assur Reqd: N l :::::::::::::::::::::::::::::::::::::::::
LICENSE FEE TRANSMITTAL A. REGION Z
- 1. APPLICATION ATTACHED Applicant / Licensee: V. A. MEDICAL ' CENTER Received Date: 19990203 Docket No: 7001331 Control No.: 126500 License No.: SNM-1305 Action Type: Termination
- 2. FEE ATTACHED Amou.n t s ____ ____
Check No.: __ _____
- 3. COMMENTS Signed ___ I _kr_ ________
Date _________ d _I_bf9 _______
B. LICENSE FEE MANAGEMENT BRANCH (Check when milestone 03 is entered /__/)
- 1. Fee Category and Amounts _________________________________________
- 2. Correct Fee Paid. Application may be processed for Amendment ______________
Renewal ______________
License ______________
- 3. OTHER __________________________________
Signed _________________________________
Date _________________________________
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