ML20205C091
| ML20205C091 | |
| Person / Time | |
|---|---|
| Site: | 07002116 |
| Issue date: | 06/27/1985 |
| From: | Beattie J LAWRENCE GENERAL HOSP., LAWRENCE, MA |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20205C061 | List: |
| References | |
| 04250, 22160, 4250, NUDOCS 8509200086 | |
| Download: ML20205C091 (3) | |
Text
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One General Street. Lawrence, Massachusetts 01842 Tel. (617 )683-4000 L = 056 55 oo-030;L June 27, 1985 QQ {@
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Nuclear Regulatory Commission
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SUBJECT:
Notice of Violation, Docket #070-02116 A
In 1975, this hospital was issued License #SNM-1578 for the implantation of nuclear pacemakers.
Names on the license application were the hospital administrator, three thoracic surgeons, and a cardiologist.
Under this license, two pacemakers were implanted in 1976.
One of these pacemakers was explanted in February 1985 and this was returned to the manufacturer, Arco Medical Products Company, with the appropriate paper work.
That incident was my first knowledge of this license.
Since we no longer intend to implant any additional nuclear pacemakers, it was suggested that we cancel this license.
I now understand that this is in violation of NRC regulations.
The license apparently expired in 1981.
In order to comply with NRC policy, I am requesting that this license be reinstated, solely for the purpose of following the one patient with a nuclear pacemaker implanted.
When the pacemaker is explanted, we intend to return it to the manufacturer and terminate the license.
No additional nuclear pacemakers will be implanted.
The patient involved is currently under the regular card of one of the physicians originally named on the license application.
We intend to follow all protocols as contained in the original application.
The pacemaker involved was manufactured by Arco Medical Products Company and it is Model #NU-5D-592, Serial #B-251 83-481.
An ammendment or extension of the license was applied for in 1977 to cover Cordis pacemakers, but none of these were ever received or implanted and we do not need this portion of the license in effect
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The name of the hospital Administrator on the original license, R.
Ashton Smith, should be changed to the current Administrator Thomas F.
Hennessey.
We currently hold a Nuclear Medicine license for diagnostic and limited theraputic purposes.
This license # is 20-05655-01.
I under-stand that no fee for the pacemaker license re-application is necessary.
Now that we in the Department of Nuclear Medicine are aware of the necessity for maintaining the license until the outstanding pacemaker is returned, we will do everything to assist those named in the license application to comply with all NRC regulations.
Sincerely, aaW M
James W.
Beattie, M.D.
Director of Laboratory Medicine JWB/jt
E 5XEh:. Williet O. Mib, Chief O
License fee Manggenent Erench Of fice of Adctnistration John E. Glenn, Chief Nucicar Materials Section B Division of [ngineering and Technical Programs LICENSE FEE TRANSMITTAL NO A.
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APPLICATION ATTACHED Applicant / Licensee:
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Amount:
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LICENSE FEE MANAGEMENT BRANCH 1.
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Correct Fee Paid.
Application may be processed for:
Amendment Renewal License
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REGION I FORM 213 (PARCH 1983)