ML20216F608
| ML20216F608 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 09/11/1999 |
| From: | Wright G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Swanson C MEDTRONIC, INC. |
| References | |
| NUDOCS 9909220132 | |
| Download: ML20216F608 (2) | |
Text
_- ___
r g KaC UNITED STATES
, o. NUCLEAR REGULATORY COMMISSION
[ n REGION 111 g y 801 WARRENVILLE ROAD
- LISLE. ILLINOIS 60532-4351
\...../
September 11, 1999 Charles Swanson, Vice President, Chief Quality and Regulatory Officer, and Radiation Safety Officer Modtronic, Inc.
7000 Central Avenue N.E.
Minneapolis, MN 55432
SUBJECT:
NRC INSPECTION
Dear Mr. Swanson:
This refers to the inspection conducted on August 11,1999, at Medtronic, Inc., Minneapolis, Minnesota, with continued NRC in-office review through August 30,1999. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. The NRC in-office review involved additional telephonic interviews of your staff about an event that involved your assistance in trans'arring a nuclear powered pacemaker device (Cordis) from your facility to another licensee in Florida (Accufix). On August 30,1999, at the conclusion of the inspection Mr. Thomas Young of my staff discussed our findings with you by telephone.
1 During the inspection period, your conduct of licensed activities was generally characterized by safety-conscious operations and sound health physics practices in the recovery, analysis, and storage of explanted nuclear pacemakers. In particular, on March 26,1999, individuals from i Accufix and Washington Hospital Center contacted your Retum Product Receiving staff in the j Cardiac Pacemaker Unit of Cardiac Rhythm Management about a Cordis device that was inadvertently shipped to Medtronic by Washington Hospital Center. Your staff cooperated promptly by identifying the device, obtaining appropriate packaging materials from Accufix and retuming the device to Accufix on April 1,1999.
No violations of NRC requirements were identified during the course of this inspection.
However, we are concemed about the number of nuclear powered cardiac pacemaker devices that have not been retumed to you as of your annual report that was transmitted by your letter dated November 1,1998.
Based on your discussions with our inspector, we understand that your next annual report will provide additionalinformation about the devices that have not been retumed to Medtronic. For example, you have additional information in your possession about the distribution and tracking of each device, e.g., pacemaker device serial number, nuclear battery serial number, dates of ,
transfer and implantation, licensee (nanse, contact individual, mail address, e-mail address, I telephone number, etc.), dates and nature of contact between you and each licensee, dates '
and nature of contacts between each licensee and each patient, dates and nature of transfers of batteries and/or devices from one licensee to another licensee. It would be helpful if you y
9909220132 990911 PDR ADOCK 07001209 C PDR l
C. Swanson would provide the information in a written tabular format and electronic version. If your intent differs from our understanding, contact me at 630/829-9602 or Mr. Young at 630/829-9835.
In accordance with 10 CFR 2.700 of the NRC's " Rules of Practices," a copy of this letter will be placed in the NRC Public Document Room.
We will gladly discuss any questions you have conceming this inspection. Thank you and your staff for the cooperation and courtesy given to our inspector.
Sincerely,
/s/ G.C. Wright I Geoffrey C. Wright, Chief l Materials inspection Branch Docket No . 070-01209 License No. SNM-1156 cc: Larry Paulsen, P.E.
Distribution:
Docket File PUBLIC IE-07 J. L. Caldwell, Rlli C. D. Pederson, Rlli Rlli Enf. Coordinator EJM, Ril (e-mail)
LEO (e-mail)
DOCDESK (e-mail)
Greens
-e o t' ,o r DOCUMENT NAME: G:\SEC\07001209.991 To receive a copy of this document, Indicato in the box:"C" = Copy without enclosure "E"= Copy with enclosure"N"= No copy OFFICE Rlli lC Rlli , l l l NAME Young /djp % Wright P44d DATE 09//ty99 09////99 OFFICIAL RECORD COPY