ML20212D887
| ML20212D887 | |
| Person / Time | |
|---|---|
| Site: | 07003042, 07002876, 07001369 |
| Issue date: | 05/20/1986 |
| From: | Farsetta J VETERANS ADMIN. MEDICAL CENTER, BROOKLYN, NY |
| To: | Taylor M NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20212D767 | List: |
| References | |
| 105572, NUDOCS 8608120583 | |
| Download: ML20212D887 (3) | |
Text
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Medic:1 C:nt:r b) 800 Poly Placa o
.c Brooklyn NY 11209 bMS K Wterans k Administration 0 T - Oy // Z_
WAY 20 386 In Reply Refer To: 527/11D Ms. !!arlene Taylor Material Licensing Branch U.S. Nuclear Regulatory Commission 631 Park Avenue King of Prussia, PA 19405 SUBJ:
!!aterial License for Plutonuim - 238 Nuclear Powered Pacemaker 1.
The Brooklyn VA Medical Center hereby applies for License to possess, for the purpose of patient follow-up, the Laurens-Alcatel flodel 9000 Isotopic Generator (Nuclear Pacemaker).
During the years 1973-1975, six such pacemakers were implanted in patients at this Medical Center, under the provisions of our previous License Nos. SNM 1358 and SNM 1823 (Attachment A).
Although our most recent license expired on July 31, 1983, one of six patients in whom we implanted a nuclear powered pacemaker remains in follow-up care at the tie 'ical Center.
2.
The following information is supplied in support of this application:
a.
Institution Name:
VA Medical Center
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800 Poly Place Brooklyn, New York 11209 b.
Number of Plutomium Pacemakers Authorized:
The original license authorized implantation of fifty (50)
Laurens-Alcatel flodel 9000 Pacemakers in connection with our participation in a clinical investigation on the prolonged effects of nuclear pacemaking.
Detailed information about the pacemaker is included in Attachment B.
Six flodel 9000 pacemakers were implanted between 1973-1975, and one patient remains in the follow-up care.
This application requests approval to continue the follow-up care of this patient until pacemaker failure, removal, or patient expiration, at which time the pacemaker will be disposed of as specifled, and the license will be terminated.
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SUBJ:
527/11D c.
Activities to be Conducted Under the License:
License is requested for the purpose of follow-up care of one patient with an implanted Laurens-Alcatel Model 9000 Isotopic Generator, and to return the device to the manufacturer for proper disposal at the time the pacemaker is explanted.
No new pacemakers will be implanted.
d.
Physicians Involved in the Plutonium Pacemaker Program (Curricula Vitae Attached)
Vincent A. Piccone, Jr., M.D.
Chief, Thoracic Surgery VA fiedical Center 800 Poly Place Brooklyn, New York 11209 (718) 836-6600 Extension 251 Specialty Board Certifications:
The American Board of Surgery, 1965 The American Board of Thoracic Surgery, 1967 Licenses:
New York State (82205)
Pennsylvania (MD-031619-E)
John Fontaine, M.D.
VA Medical Center 800 Poly Place Brooklyn, New York 11209 (718) 836-6600 Ext 317/318 Specialty Board Certifications:
The American Board of Internal Medicine, 1982 The American Board of Cardiology, 1985 License:
New York State (144286) 3.
Please be advised that although our most recent license expired in 1983 we ve, since that time, continued to abide by the con41 tion ard requirements of the license.
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or Attachments
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ATTACHMENT "A"
NUCLEAR REGULARTORY LICENSE l
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