ML20248F410
| ML20248F410 | |
| Person / Time | |
|---|---|
| Site: | 07002908 |
| Issue date: | 06/02/1989 |
| From: | Fletcher J, Shabetai R, Trujillo T VETERANS ADMIN. MEDICAL CENTER, SAN DIEGO, CA, VETERANS ADMIN. MEDICAL CENTER, WASHINGTON, DC |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V) |
| Shared Package | |
| ML20248F396 | List: |
| References | |
| 71005, NUDOCS 8910090014 | |
| Download: ML20248F410 (3) | |
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Medic 1 C:nt:r 3350 La Jolls Village Drive San Di;go CA 92161 M Veterans W /tdrninistratiori June 2, 1989 in Reply Refer To: 664/111A Materials Licensing Branch U.S. Nuclear Regulatory Commission Region 5, Suite 210 1450 Maria Lane Walnut Creek, CA 94596 Thru:
James Fletcher, M.D.
Director of Nuclear Medicine (115)
VA Central Office Washington, D.C.
20420 RE:
Renewal of Current License No. SNM1859 Gentlemen:
This is in reply to your recent letter reminding us of the need to renew our license to implant or follow patients with plutonium-powered pacemakers.
We currently have just one nuclear pacemaker patient which we are following in our Pacemaker Clinic.
Therefore, we will have to renew our current Nuclear Regulatory Commission License to have a nuclear pacemaker under our control.
The one patient we are currently following has a Medtronic's plutonium-powered pacemaker, Model 9000, implanted.
The following information is submitted in application to renew our Nuclear Regulatory Commission License SNM 1859 to implant or follow patients with plutonium-powered pacemakers:
a.
Applicant:
San Diego Veterans Administration Medical Center 3350 La Jolla Village Drive San Diego, CA 92161 b.
We have one (1) nuclear pacemaker authorized under our current license.
We would like to continue to have authorization to follow one patient who has a
Medtronic's model 9000 plutonium-powered pacemaker implanted.
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" America is #1-Thanks to our Veterans"
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Materials Licensing Branch U.S. Nuclear Regulatory. commission c.
The physician responsible _for following 'this patient is:.
Ralph Shabetai,
.M.D.,
F.R.C.P.,
Chief, Cardiology; Section San Diego Veterans Administration Medical Center-3350 La Jolla Village Drive San Diego, CA 92161 Telephone:
(619).-453-7500, Extension 3817 License to-practice in Ohio, Kentucky, Texas and.
California' i
= Board Certifications:
E.C.F.M.G. Standard Certificate
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American Board of Internal Medicine' Subspeciality Board, Cardiovascular Disease Dr. Shabetai 'has extensive experience with the use'of pacemakers dating from 1961.
He has been at the San Diego VA -Medical Center since 1976.
He has at least two publications :concerning. pacemakers; cne. paper concerning pacemaker failure,'and a second concerning transvenous implantation of pacemakers.
Dr. Ralph Shabetai is Coordinator of the. Pacemaker Clinic.
'At the present time, approximately '16p'hel. Pacemaker Clinic.are being
- patients followed at regular intervals in.,t
- However, more than percent' ofL the pacemakers implanted at this institution are by the transvenous route.
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d.
We are asking for no changes in our current license program under our new licensing request.
e.
As part of-this
- renewal, we agree to continue the follow-up, reporting and recovery procedures required
.under Medtronic's Protocol and by the U.S.
Nuclear Regulatory Commission.
In addition to this -Nuclear Regulatory Commission. License,-
l No. - SNM1859,. We have a much.more extensive Nuclear Regulatory Commission License, No. 04-15030-01.
Under this other license, we have a
large radiation safety program established.
The Nuclear Pacemaker License.will come under the same control established to administer the larger program.
We hope this
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Materials Licensing Branch U.S. Nuclear Regualtory Commission letter will suffice for our renewal request.
If additional information is needed, we will gladly provide it.
Sincerely, oh RALPH SHABETAI, M.D.
Chief, Cardiology Section THOMASTR[nterDirector ILLO Medical Ce
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bA ETCHER, M.D.
j ES W. uck Medicite Service (115)
Dir Veterans Administration Washington,DC 2M20 O