ML20153D104

Application for Amend to License SNM-1156,amending License to Include 1991 Annual Rept,Increase Possession Limit for Plutonium-238 & Confirm T Hawkins as RSO & Chairman of Radiation Safety Committee

ML20153D104
Person / Time
Site:	07001209
Issue date:	12/05/1991
From:	Swanson C MEDTRONIC, INC.
To:	Hueter L NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
Shared Package
ML20153C940	List: ML20153C937 ML20153C964 ML20153C993 ML20153D009 ML20153D021 ML20153D042 ML20153D051 ML20153D070 ML20153D090 ML20153D104
References
SSD, NUDOCS 9809240314
Download: ML20153D104 (3)

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[f Bet Control No,92024 Renewal for Medtronic Ucenso SNM.1150

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' Deaf Mr, Hueter.

b The purpose of this letter is to amend our renewal appik:ation for the reforenced licenso

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inMlaty ynnted on tieptember 30, 1909. The amendment is bnsed on discussions M

between Mr. t.oren Hueter of NRC and Dr. Charles Swanson of Modtronic. We wish to

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amend our ILcense apphcatkm in the following respects; e

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Modtronic has submitted annual reports as required by the licenso to the attention of G'

Ms Pattkia Vacca, NRC in Washington. A copy of the 1991 report is includod as 1.g,. Future annual reports wid be provided both to Washington and Region 3 t

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ffnimum Possession UmM h.p",',,. The current possession limit for nuclear matorial is 125 grams records and determined that an Individual power source contains no more than y/f x '

O.21 grams of Plutonium 238. With the 471 explanted pacomakers currently in our J

N < j.- posst,/.slon, we are within the curront limit. It could be excooded, however, if all 648 are ip s explanted and retumed to Modtronic. To ensure complianco, we therefore request that hg our possession limit be increased to 150 grams of Plutonium 238.

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Bad!al!on Safety Off!cor s%-

We wish to confirm as indicated on pago 3 of our August 8,1991 renewal application that Mr. Thomas Hawkinson is both our Radiation Safoty Officer and Chairman of our S

. -Radiation Safety Committoo. A copy of our August 8 application is provided for f

convenlonce as Attachmont 2.

T RECEIVED

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DEC 1 G 1991 DEc 1 G M

.h 98o924o314 98o916 REGION 111 PDR RC SSD PDR svu(- e v yy

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. Location of the Physioloolcal Research Laboratorv J Q. Q' 3' Our August 8 appilcation listed an address for the Physiological Research Laboratory i

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. hich is different from that listed in our previous license. This is to inform you that this w

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• is an administrative change of address only. The facility and its physicallocation have not.

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p changed. On further review, we have determined that no analysis, testing or storage of Model 9000 pacemakers or their nuclear power source has occurred at that facility in the

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g[y{k' ;',' past several years and no furthe j);Y t

Jtherefore request that the license be amended to delete the Physiological Research.

Laboratory as an authorized facility. Finally, all testing that was done at that facility.

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involved sealed sources and appropriate tests have been conducted and have' determined I

?;$;.t' that no leakage occurred while units were tested, analyzed or stored at that facility.

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[$l Exemotion from Leak T5stino R' auirement for Stored Units' e

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- Based on our discussion, we have determined that the specific exemption from routine tGP leak testing of units in storage was inadvertently omitted from our 1986 license.- We -

AQ, M therefore request that this exemption be reinstated and Medtronic agrees to abide by the i Ji1

. conditions stated as follows:',

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"The periodic leak test required by the condition does not l; f '

apply to sealed sources that are stored and not being used.

l ME The sources exempted from this test shall.be tested for

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leakage prior to any use or transfer to other persons unless C -[

they have been leak tested within the 6 months prior to the

Zi date of use or transfer."

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'U If you have any questions.or comments about the information provided above, please

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. contact me.-

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Sincerely,

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' MEDTRONIC, INC.

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.7 Charles H. Swanson, Ph.D.

Mf l Director, Regulatory Affairs M '.V, '

W Cardiac Pacing Business M'

(612) 574 3409 f

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(612) 574-6424 FAX p

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%IllTRODUCTIoll 4

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. "j;Sik hundred sixty-two (662) patients have boon implanted with Medtronic -

i i.*? Model : 9000; isotopic pulso generators, or nuclear-powered pacemakers in-

. the"' United'. States : since 1972,. according. to reports submitted to b,l['lMedtronic..'PhysiciansandLhospitalsllcensedtoimplantthesedevices 3 E_ hhave:done so under:a clinical investigation plan approved by the United i9

(.;{ States < Nuclear,RegulatoryCommission.

hNih T e Model-900d performance has been documented'in ninctcen (19) previous.

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($h),E 4 evaluation: reports.n ;Results conclusively. demonstrated that the Model' t'd?. 9000 f is ~at. least as ; reliable as chemically-powered units..

However,,,

hD' " improved longevity-of chemically-powered unitu, primarily lithium, have :

S "7 considerably decreased the need for a nuclear-powered unit.

Thereforo, Tg%.h,Medtronic-is no. longer selling the Model 9000 pulso generator with a

$ 4.W nuclear power source, w w.

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W N.TIThis summary' documents therstatus of'the Model 9000 pulse generator as

)fibiof October,1991, and updates the previous summary of october,1990..

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<;ph:.. for-all nuclear devices will not be maintained.

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I WG G. Attachment Q" ~ f;,,M g

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'Currente status of the Model 9000 pulso generator,

f. p h :q 1II.J Explants not.previously reported.

hl, III. Review of failures.

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h,IV. SStatement of.Model.9000 accountability.

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( G;, Previous Reports

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'$.;;M{W:Medtronic,, Inc.,', S tatus Report Ito. 1 of the Clinical study of the i

OC Medtronic ' Laurens-Alcatel Model 9000 Isotopic Pulse Generator.

i ay;/$l Minneapolis,UnpublishedManuscript, f- !!ovember 20, 1973. l f@ & q l _w i a. W Ibid., Status Report?Ifo. 2,' June 28, 1974 j ,lp,' / Ibid., Status Report !!o. : 3,4 flovember 24, 1974 '/ W Ibid.,? Status Report flo. 4, May 24, 1975 i jdhl7 Ibid.,,StatusReportlio. 5,.!!ovember 24, 1975 i l 4,k 1 Ibid.,. Status Report tio. 6, May 24, 1976 j e,r Q*. 1 Gy' s

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