ML20153D042
| ML20153D042 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 03/10/1993 |
| From: | Kennedy J MEDTRONIC, INC. |
| To: | Grobe J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20153C940 | List: |
| References | |
| SSD, NUDOCS 9809240284 | |
| Download: ML20153D042 (5) | |
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Medtronic@
/(.XX) Central Avenue N I M,nneapolis. MN bb43? 3S /6 f olophone (61?) 574 40fX)
SENT BY CERTIFIED MAIL Catste Medinin<. T ele n a ows
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RETURN RECETPT REQUESTED March 10, 1993 Mr. John A.
Grobe Nuclear Materials Safety Branch l
U.S. Nuclear Regulatory Commission Region III 799 Roosevelt Road Glen Ellyn, IL 60137 Re:
MEDTRONIC, INC.
I' LICENSE NO. SNM1156
Dear Mr. Grobe:
Please be advised that Thomas Hawkinson, the-individual identified in Conditions 11 and 12 of our Materinis License au the chair of the Radiation Safety Committee and the Radiation Saf ety Of ficer, is longer an employee of Medtronic, Inc.
no Until we find a replacement to assume all of Mr.
Hawkinson's i; capon' ib'ilities, Charles Swarison'will annume~ these speci t-ic dutica-s and responsibiliticut Attached pleario find a do" credentials.
Please let me know if you have any questio
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RADIATION SAFETY OFFICER MEDTRONIC, INC.
i LICENSE NO. SNM1156
,i s i Charles Swanson
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'Vice President, Regulatory Affairs
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i Responsibilities:
Obtaining and maintaining regulatory approval for Medtronic'n pacing products from FDA and other applicable regulatory j
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NRC-Related Activities:
Responsible for maintenance of the license from NRC for the Model 9000 nuclear powered implantable cardiac pacemaker since 1977.
i Academ i c Backgr<' tin -i -
Ph.D., Biophysics, Harvard University Radiation Safety
- Officer, Biophysical 1.a bo ra t o ry, Harvard Medical School B.S.,
M.S.,
Chemical Engineering, University of Minnesota 1
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0 PRIMARY PGM CODE : 22160 SECONDARY PGM CODES:
INSPECTION REGION: 3 PRIORITY CODE: 7 INSPECTION CATEGORY: K l
- 000 000 **
vm2.nrc, gov 09:17:13
<<NUDOCS/AD>>
TCON75 Nuclear Regulatory Commission' Version 002.000
-Records 1 5=== Subject / Field / Boolean Results = Select Count 56
Accession #
Docket Author Name Affil Issued Microfiche Address 9310120206 07001209 NE R3 930716 76757-012/76757-021-
'(0)
Amend 22 to license SNM-1156, authorizing use of listed licensed matl.
'9309160248 07001209 WEISS,D.
NECCNTF 930608
.76448-309/76448-313-
-(0)
Considers encl application from Medtronic,Inc'to be abandoned
'for nonpayment of fees.
'9202250032 03017993_ GROBE,J.A.
NE R3 920214 60668-072/60668-084 (0)
Ack receipt of 920116 & 23 ltrs informing NRC of steps taken to correct violations noted in~insp of licenses SNM-1156 &
9202140088 07001209 HUETER,L.J.
NE R3 911227-60603-150/60603-181 (0)
Matls licensing 1 package for amend 21 to license SNM-1156 for Medtronic,Inc. Control:392024.
9112240100 03017993 GROBE,J.A.
NE.R3 911218 60078-060/60078-062 (0)
Discusses insps of licenses 22-13456-02 & SNM-1156 on 911127 &
forwards-notice of violation.No violations identified for i
Arrows-Scroll, ENTER-Select, F10-Mark For Download, CTRL-F9-Continue Download.
Char Mode: Replace Page 1 Count:
- 5 DG1.nrc. gov 09:19:14 ceNUDOCS/AD>>
TCON75 Nuclear Regulatory Commission Version 002.000
- = Records 1 5=== Subject / Field / Boolean Results = Select Count 56 =
Accession #
Docket Author Name Affil Issued Microfiche Address 9310120206 07001209 NE R3 930716 76757-012/76757-021 (0)f
. Amend 22 to license SNM-1156, authorizing use of listed licensed l
matl.
9309160248 07001209 WEISS,D.
NECCNTF 930608 76448-309/76448-313 (0)'
Considers enc 1 application from Medtronic,Inc to be abandoned for nonpayment of; fees.
.~9202250032 03017993 GROBE,J.A.
NE R3 920214 60668-072/60668-084 (0)
Ack receipt.of 920116 & 23 ltrs informing NRC of steps taken to l
correct' violations noted in-insp of licenses SNM-1156 &
9202140088 07001209 HUETER,L.J.
NE R3 911227 60603-150/60603-181 L
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Matls licensing package for amend 21 to license SNM-1156 for
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9112240100 03017993 GROBE,J.A.
NE R3 911218 60078-060/60078-062
'Medtronic,Inc. control:392024.
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-(0)
Discusses insps of. licenses 22-13456-02 &'SNM-1156 on 911127 &-
forwards notice of violation.No violations identified for i
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Estimates of Pu-238 Pacemaker Batteries Implanted and in Storage G. W. Roles i
Regulatory Branch l
Olvision of Low-level Waste Management and Decommissioning l
February 3, 1989 l
This presents an estimate of the number of Pu-238 pacemaker batteries which may be candidates for discard over the next five years.
ll Approach
[t Telephone conversations were held with representatives of the four manufacturers currently licensed by NRC or an Agreement State to possess and
-f store Pu-238 pacemaker batteries.
Medical institutions authorized to implant nuclear powered pacemakers are required, by license condition, to return unneeded or explanted units to these manufacturers.
The following individuals
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were contacted, all on February 2, 1989:
Dr. Stephen Gertz, Radiation Safety Officer of Roy F. Weston, Inc. (the 5
contractor for ARCO, a company no longer distributing pacemaker h
batteries),
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- Joe Klingensmith of Biocontrol Technology, Inc. (formerly Coratomic, k
Inc );
Tom Hawkinson of Medtronic, Inc.; and f
Jay Harmon of Teletronics and Cordis Pacing Systems (TPL, formerly Cordis,
- j Inc. )
Summary of Telephone Conversatons M
Roy F. Weston.
Dr. Gertz said that the company has 25 pacemaker batteries in storage, and would like to transfer all to another party for storage or h
disposal.
Each battery contains about 8 curies of Pu-238.
In addition, 50 to n
55 pacemakers are still implanted.
The company would like to transfer these remaining batteries when they are explanted and returned.
@d Biocontrol Technology.
Biocontrol received 594 battery units, of which some are at the facility and some are implanted.
Of the 332 batteries in house, 16 d
have been placed in pacemakers to be sold, leaving 316 batteries in storage.
h Each battery contains abot,t 4 curies of Pu-238.
Mr. Klingensmith did not believe that they wished to transfer the stored batteries at this time, as the k
batteries are still usable.
Biocontrol has recently gotten approval for a new h
pacemaker model.
But Pu-238 has an 86 year half-life, and af ter 20 to 30 years
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the batteries will no longer be usable.
At that time the batteries will have to be discarded.
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PACEMAKERS Medtronic.
Medtronic has received about 2000 batteries, of which about 1800 are implanted and the remaining 200 are in storage.
Each battery contains about 2.5 curies of Pu-238.
in about seven years, Mr.
Although Medtronic has not implanted a pacemaker the stored batteries for another 5 to 10 years.Hawkinson felt that Hedtronic woul concern regarding possible product liability suits.The rea on he gave was a legal Apparently, Medtronic's legal staff believes that in the event of a suit, the company would need the batteries to demonstrate that their product was safe.
After another 5 to 10 years, Medtronic should be safe from such suits.
TPL.
TPL has about 120 batteries in storage and has implanted about 200.
battery is triple encapsulated and contains from 3 to 4.8 curies of radioactive Each material, mostly Pu-238.
the stored sources, if that were possible.Mr, Harmon indicated that they would like to t Of the implanted batteries, on average about one battery per quarter is returned, or at the most, one battery per month.
Analysis The total number of batteries stored and implanted is about as follows:
Company No. Stored No. Implanted Total Arco 25 55 80 B l.ocon t ro l 316 278 594 Medtronic.
200 1800 2000 TPt 120 200 320 Total; 661 2333 2994
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Of these 3000 batteries, about 150 would be immediately discarded or transferred to another party, if that option was available.
These 150 i
batteries would be contributed by Roy F. Weston and TPL.
We estimate that within five years 30 to 50 additional batteries would be discarded by these companies.
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Regarding Coratoelcs and Medtronics, it is more difficult to make a projection; company decision to discard stored batteries depends on legal and business d
i consideraticos.
If half the stored batteries are to be discarded over the next five years, then this implies about an additional 260 batteries.
Based on these assumptions, we estimate 450 batteries to be discarded over the next five years.
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