ML20248E272
| ML20248E272 | |
| Person / Time | |
|---|---|
| Site: | 07001398 |
| Issue date: | 04/20/1988 |
| From: | Finkbennett D, Forsaith A, Matzick K WILLIAM BEAUMONT HOSP., ROYAL OAK, MI |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20248E242 | List: |
| References | |
| 85505, NUDOCS 8904120190 | |
| Download: ML20248E272 (4) | |
Text
.
= g i
4 l
William Beaumont Hospital Medical Physics and t
- Royal Oak Radiation Safety Office April 20, 1988 l
l' Unites States Nuclear Regulatory Commission Region III Material Licensing Section 799 Roosevelt Road Glen Ellyn, Illinois 60137 Re: Renewal of License Number SNM-1366 expiration date 06/30/88 Gentlemen:
We wish to renew our nuclear power pacemaker license SNM-1366. The information in this letter follows the instructions in Termination, Renewal and Fee Information for Institutional Nuclear Pacemaker.
I. Termination: Not applicable II. A. Renewal is appropriate because:
- 1. We are currently following five patients who each have a Medtronic Model #9000 nuclear pacemaker.
- 2. We will have nuclear pacemakers in our possession at the time any need to be returned to the manufacturer, or are to be implanted.
- 3. We want to maintain the option of impiat) ting; a nuclear pacemaker l
should conditions warrant such act'lon.
co.
ca B. a. License to be renewed:
SNM-1366m l
- b. William Beaumont Hospital Corpordion g i
3601 West Thirteen Mile Road
~
F, Royal Oak, Michigan 48072 i'.
C
]
Radiation Safety Officer, Ann L. Forsaith 3
- c. Authorization is requested for:
M n @:
- 1. 10 individual sources not to exceed 210 milligrams each, sealed a c sources of Plutonium (principal radionuclides Pu-238) for implanta-tion in humans as a component of Medtronic Model #9000 nuclear-m powered cardiac pacemaker for clinical purposes, m
oo
- 2. 10 individual sources not to exceed 250 milligrams each, sealed 6
sources of Plutonium (principal radionuclides Pu-238) for implanta-M tion in humans as a component of Coratomic Model C-101 nuclear-nl.J n powered cardiac pacemaker for clinical purposes.
e n$-
- d. Activities to be conducted under the license.
0wz
- 1. To continue to receive and implant nuclear-powered pacemakers, if ma:m conditions require such pacemakers, follow patients with implanted devices on a semi-annual basis, and return explanted pacemakers to the manufacturer for proper disposal.
(-
l i
5
.. ~
r, Jt/tr w?
We l V E '
MAY 311988 l
u 2 u:/u/(een
)_
O/
- 3@.
I 380, ANoaa aoyai aat u,<ninen C' 3 2 48072 2793 <3,3i288-8373 did.:.M db.
VHA,w e e,wmum m.
EGECII CONTROL NO 8 s 5 0 5
e Physicians who are involved in the pacemaker program are:
e.
Gerald C. Timmis, M.D. on original license Seymour V. Cordon, M.D. on original license Renato C. Ramos, M.D. see attachment Douglas C. Westveer, M.D. see attachment
- f. For this renewal, we request deletion of all letters in condition 16 and replace such documents with the following:
- 1. The manufacturer's protocols will be followed.
- 2. Patients with implants will be followed by semi-annual follow-up visits to the Pacemaker Clinic.
- 3. The NRC will be notified of the death of any patient, the explanta-tion of any pacemaker, and the loss of any patient to follow-up visits.
- 4. The physicians are as listed in II-B-e.
- 5. If conditions so warrant new implants, the pacemakers will be im-planted at William Beaumont Hospital, Royal Oak,.the patients will be followed at either the Royal Oak Hospital or the physician's (as listed above) offices.
III. Fee B. No fee is required as we hold NRC license #21-01333-01 t
(Jadii k d KennethMatzick,Wreepr,WilliamBeaumontHospital,RoyalOak
^
, }
. /
f
')
</f sp;
/]({~
f Darlene 'Fifik-Be,rinett, M.F., Chairperson, Radiation Safety Committee M
&nn L. Forsaith, M.P.H., Radiation Safety Officer 1
I l
l i
l I
l l
e:\\ms\\msdata\\snm-1366. doc I
ggjy,g C0%ct7,cp l
) 05 1
1 j
A.
Douglas C. Westveer, M.D.
Office address:
Cardiovascular Disease 29829 Telegraph Rd. #200 Southfield, MI 48034 office phone #
(313) 350-2220 State Licensure Michigan 36481
~
Intern 1 Medicine and Cardiovascular Diseases Specialty Board Certification Position at William Beaumont Hospital Attending Cardiologist and Director, Electrophysiology Laboratory Experience with Pacemakers 35-50 implants per year I,
Douglas C. Westveer, M.D. am familiar with the manufacturer's NRC-approved prot ol and I agree to follow that protocol.
Us k h_L Douglas W
't er, M.D.
./
William Beaumont Hospital 5.
License # SNM-1366 Date April 20, 1988 e
)
l l
I e:\\ms\\sna-1366. doc CON [cq,
1
)
O Renato G. Ramos, M.D.
Office address:
Cardiovascular Disease 3535 West Thirteen Mile Rd. #205 Royal Oak, MI 48072 Office phone #
(313) 288 2218 State Licensure Michigan '32739 Specialty Board Certification Position at William Beaumont Hospital Attending Cardiologist fj Experience with pacemakers M
f(A)Ln y%
QfWk k
- }./M&r /
"y
(&
le 0 ^ W r*V) gm d uck
-/re adh s d. e--a f
7 y g yy & it
&%m x
M Twenty years experience with the implantation, follow-up and management of pacemakers. This includes troubleshooting and revision of pacemaker systems.
I, /J A &n am familiar with the manufacturer's NRC-approved protocol and I agree to follow that protocol.
M.
b.
C"4'* V/
Fenato [G. Ramos, M.D.
g
,f-William Beaumont Hospital 7/
License # SNM-1366 Date'/
April 20, 1988 f"w;,'d //().6 l
e:\\ms\\snm 1366 doc 53g 5 l