ML20206K773
| ML20206K773 | |
| Person / Time | |
|---|---|
| Site: | 07001396 |
| Issue date: | 04/28/1986 |
| From: | Dagenais J HURLEY MEDICAL CENTER, FLINT, MI |
| To: | Mallett B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20206K735 | List: |
| References | |
| 25862, 81207, NUDOCS 8704170079 | |
| Download: ML20206K773 (2) | |
Text
r i*a HJRLEY NEDIGI. CEMER OM HJRLEY PLA7.A,FLNT,MCHIGAN 48502 PHONE (313) 257-9000
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M r,D 5E Ei April 28,1986 E
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Bruce S. Mallett, Ph.D., Chief
.3c Materials Licensing Section United States Nuclear Regulatory Commission Region til 799 Roosevelt Road Glen Ellyn, Illinois 60137
SUBJECT:
Request for on Amendment to License No. SNM-1393 Dated June 6,1985 and your Request for Additional information Dated November 25,1985 and January 31,1986
Dear Dr. Mallett:
It is our understanding that you are not able to terminate our license authorizing the use of plutonium in cardiac pacemakers until all of our units have been recovered. For this reason, we wish to amend our license for inclusion of a physician, Wayne Breece, M.D. who will be responsible for the explantation, recovery and disposal of remaining pacemakers.
In support of this request, the following information is provided:
1.
Dr. Breece's specialty is Cardiology. He is not Board certified and is an active attending physician at Hurley Medical Center.
2.
Dr. Breece recently explanted a pacemaker on Monday, January 27, Q
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l986 (Medtronics Serial #5R0042). Dr. Breece continues to follow one of Hurley's two remaining patients on nuclear pacemakers.
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3.
Currently, explantation of pulse generators, if possible, is done in the
,ogg Cardiovascular Study Unit. A semi annual follow up program is in effect. Dr. Breece is familiar with Medtronics protocol and technical o-&
O-S manual for the Medtronic TM Laurens-Alcatel Model 9000 and eni understands that the issuance of a license is conditioned upon the use ROE of this protocol and has been familiarized on the following of the sem instructions and the technical manual regarding " transporting, handling and sterilization of the pulse generator", and " comments on implantation procedure (myocardial leads)."
RECEIVEL Originally, the above referenced request was assigned to control number 25862.
yeverj the time elapsed between requests for additional information and gY 011986 RECEIVED BY.
o[mahhn provided may require that this be assigned another control number.
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B}uca S. Mollstt, Ph.D.
Page 2 April 28,1986 in addition, license amendment number 5, to license number SNM-1393 dated April 15,1986, cites amendments requested in a March 6,1986 letter. We do not i
have a record of this correspondence in our file. I believe that the reference cited is a January 6,1986 correspondence, and would ask that your of fice recheck this amendment request.
if you have any questions, or require additional information regarding any of these s
requests or questions, please contact my office.
Sincer y,
J Dagenais istant Direct JD:bsj:073 RECEIVED MAY 011986 REGION III i
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