ML20129G677

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Certificate of Disposition of Matls:Model 9000 Pacemaker, Explanted on 790305,returned to Medtronic,Inc Due to Erosion of Pocket
ML20129G677
Person / Time
Site: 07002678
Issue date: 02/27/1985
From: Declement F
ST. AGNES MEDICAL HOSP. PHILADELPHIA, PA
To:
Shared Package
ML20129G660 List:
References
NUDOCS 8506070339
Download: ML20129G677 (1)


Text

NRC Fewn 3{4 U.S. NUCLEAR REGULATORY COfCISSION ArreovED ev oms 3150 002s at ti21 ENU!I'd

  • PC'**"'"'"*'

CERTIFICATE OF DISPOSITION CF MATERIALS (Allitenr: MUST be completed, please print)

LICENSEE NAME ANO ADURESS LICENSE NUMSER Fredettick A. DeClement, M.D.

SNN1767 Sal.nt Agnes Medical. Center

' ' ' ' ' ' ' ' " ' " " ' ' ~

1900 Sottth Broad Stteet Philadelphia, PA 19145 THE LtCENSEE OR ANY INDIVIOUAL EXECUTING THIS CERTIFICATE ON SEHALF OF THE LICENSEE CERTIFIES THAT:(Check and/or complere the warnerinte itents) twnw.)

A. MATERI ALS DATA /Cheet one auf compiere. as necessary/

l 1. NO MATERIALS HAVE EVER BEEN POSSESSED OR PROCURED 8Y THE LICENSEE UNDER THIS LICENSE.

OR

2. ALL MATERIALS PROCURED AND/OR POSSESSED 8Y THE LICENSEE UNDER THE LICENSE NUMBER ' ITED ABCVE HAVE BEEN TRANSFERRED ON C

DATE TO WHICH HAS NRC LICENSE NUM8ER OR

] 3. ALL MA'ERIALS PROCURED AND/OR POSSESSED BY THE LICENSEE l'NDER THE LICENSE NUMBER CITED ABOVE DATE TO WHICH HAS LICENSE NUMBER ISSUED 87 THE STATE OF AN AGREEMENT STATE PURSUANT TO SECTION 274 OF THE ATOMIC ENERGY ACT OF 1954, AS AMENDED, AND THE ENERGY REORGANIZATION OR ACT OF 1974.

4.

MATE RIALS HAVE 8EEN OI$t0 SED 0F iN THE FOLLOWING MANNER. (Describe wecific divaantproceoures-if additional wace is needed, use the reverse of this form, or provide attachments)

One pacemaket aus implanted on 3/13/78, Model" 9000, Ser.ialH 5R00214 This aus explanted on 3/5/79 because of erosion of the pocket.

The pacert was returned.to Medtronic, 7nc. on

.the same dat) as explant.

A tithium pacer modeld 5989 tats then implartted.

The above data secre confirmed bi verbat communica, tion scith Mr. James Cox of Medtronic, 7nc.

j on 2/20/85.

I

8. OTHER DATA
1. OUR LICENSE HAS NOT YET EXPIRED; PLEASE TERMINATE IT.
2. WAS A RADIATION SURVEY CONDUCTED TO CONFIRM THE ABSENCE OF LICENSED RADtOACTIVE MATERIALS AND TO DETERMINE WHETHER ANY

_ CONTAMINATION REMAINS ON THE PREMISES COVERED BY THE LICENSE? (OecA onef NO YES. THE RESULTS (Check one/

ARE ATTACHED, OR

~

WERE FCRWARDED TO NRC ON (Datel 3.

THE PERSON TU EE CONTACTED REGARDING THE INFORMATION PROVIDED ON THl3 FORM

    • ' Or. DeClement, S.t. Agnes Med. Cntr. or James Cox, Medtronic l'""o~' ~u"**"

4.

MAIL ALL FUTURE C,ORRESPONDENCE REGARDING THIS LICENSE TO 8506070339 850524 REG 1 LIC70 999f-1767 PDR RETUT.N TO:

CERTIFYING OFFICIAL l0 ssGNAT i

DIRECTOR. OlVISION OF FUEL CYCLE AND MATERIAL SAFETY

[

U S NUCLEAR REGULATORY COMMISSION

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D OFFICE OF NUCLEAR MATERIAL SAFETY AND $AFEGUARDS pRiNTEo NauE ANo TITLE sSHiNGTON. DC 20sss Frede/ tick A. DeClement, M.D.

NRC Form 314 (1142)

MAR 0 51985

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UNITED STATES s*

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g NUCLEAR REGULATORY COMMISSION fg 7 g, t

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- g's, * * * * *,o',c KING OF PRUS$1A. PENNSYLVANIA 19406 531 PARK AVENUE Ju 311985 Docket No. 070-02678 License No. SNM-1767 Inquiry No. 85-01 Expiration Date: August 31, 1982 St.Agnes Medical Center ATTN: Dr. Frederick DeClement Clinical Professor of Surgery 1900 S. Broad Street Philadelphia, Pennsylvania 19145 Gentlemen:

Subject:

NOTICE OF EXPIRED LICENSE This refers to the telephone discussion between Mrs. Marlene J. Taylor of this office and yourself on January 8,1985. The subject of the discussion was the fac that NRC records show that the license identified above has expired and no re il application has been filed in accordance with Section 70.33 of Title T

fe of Federal Regulations, Part 70.

From this discussion we learned that you do not have any licensed material in your possession. Therefore, you must take the following actions:

1.

Prepare a statement which explains the method of disposal of the materials, including: what material was involved, how it was disposed of or to who it was shipped, and when this was done. The enclosed Form NRC-314 may be used for this purpose.

2.

If.the activities conducted under the expired license were subject to the reporting requirements of 10 CFR Part 20, Section 20.407, you must submit the annual report required by 20.407 for the current calendar year and a termination report required by Section 20.408 for individuals engaged in activities under the expired license.

Those reports mG t be submitted to the Director of Management and Program Analysis, U. S. Nuclear Regulatory Commission, Washington, D.C.

20555.

You are required to reply to this Notice within 30 days of the date above.

Address your reply to Region 1 U. S. Nuclearlegulatorv Commission Attention _:

~2 Chief, Nuclear MaterialrTectIon A, 631 Park Avenue, King of Prussia,-Pennsyl. _.

vania 19406.

In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and your reply will be.placed in the Public Document Room.

The responses directed by this Notice are not subject to the clearance proce-dures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.

~~

JAN 311985

~

St. Agnes Medical Center._

We request that you give prompt attention to these matters.

Should you have any questions regarding them, we would be pleased to discuss them with you.

Sir.cerely, g/pcY ohn D. Kinneman, Chief s

uclear Materials Section A Division of Engineering and Technical Programs

Enclosure:

NRC Form 314 cc:

Public Document Room (PDR)

Nuclear Safety Information Center (NSIC)

Commonwealth Pennsylvania O

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