ML20153D021

Informs That Registration NR0450D101U,issued in 1974,was Never Billed & That Materials License Authorizes Recovery, Analysis & Storage of Explanted Nuclear Pacemakers. Requests Info Re Need for Registration

ML20153D021
Person / Time
Issue date:	05/02/1996
From:	Kimberly S NRC
To:	Steven Baggett NRC
Shared Package
ML20153C940	List: ML20153C937 ML20153C964 ML20153C993 ML20153D009 ML20153D021 ML20153D042 ML20153D051 ML20153D070 ML20153D090 ML20153D104
References
SSD, NUDOCS 9809240277
Download: ML20153D021 (1)

Text

. . _ _ _ _. - . . _ . _ _ . _ _ - _ _ - _ _ . . _ . _ . - _. _

From: Sandra Kimberley To: SLB Date: 5/2/9610:00am

Subject:

MEDTRONIC QUESTION Steve, regarding registration NR0450D101U issued in '74. This is one that was never billed. The authorization on their materials license is for " Recovery, analysis and storage of explanted nuclear pacemakers.":In their '91 renewal reauest thav etated that Medtronic no longer manufactures or sells nuclear powered cardiac pEcemakers-they only receive, analyze and store explanted pacemakers. l

}

~

l 3 4 o Dthey stili need the registration when they no longer manufacture'or distribute the '

device?

Thanks. Sandy (P a* *j

t. #p f}'

p&~

l 1

I I

l

)

lI i

9809240277 980916 PDR RC

• SSD pop ,

4%wm

..g..m * .. .~ 4 4. . 4 y im est a u.s Nuct aan arcutatoav couwssioN

,,c, 1 Am 6ndmer,! 'L, o 3 )

. 4' 22 19 q'.

gl. . rep

~

}

4;'$wie by tie 'hsensee, a' 'hsen#iihereth mued authormnft the twenhee to resene, acquire,' pinwsk and )

l (nuclear materi,il dev;tneed N1om', to'use such'marerial for the pur;=nete and at the placets) designated bilow; to dehve >

l jt{perwns aMrkityed tisfy.pse n in aepordance u nh thOegulatnIn.go11;he applwahle Paries) This hceme shall be de

! , Regulatory Commnsion ruid W hereafter m cHect armi to any condelions speaned y

l '

p*,

I 1

t a, e n see

, */ '/tl

'pf

4; -

i Iriaccordance.withfletter dated!

Maich 10; 1993 j

i Medtronic , Inc l

y 4

1.1 mense nur6her ~ Stei-ll56 is awnderi in i entirety to read as follows:

f jg j- g : 7000 Central Avenue fl.t. - .-- r - -

- 'N l 4; Minnespelis, MN 55432 .

4 0 3piranon date . December 31, 1996-3 7

5 llosket of '

. Referen e N, 070 01209 .

j.

, o hyproduct. wurce. and m , . -

1 ChemNal and!ur phpa al j' neual nadear material t ot m b Maumum am.ount that lnenseci i

$- me pimen at any one time '

~ t

.. q

' under Nm lwerne -

) A. : Pluto'rilumf(Piincipalj A. Sealed; Source (s) A, 150 gramsitatalhno'-

j Lt 'ra(ioriucl ide~ Pu-238)

~

A l (Alcatel-Gipsie) ,

singleisource to' '.

ij p

. exceed:1 gram'*

Pui238 y

lg . <

'g 4

l 6 -

/l t _. ..._ ._ _. >

q 9. Author ned U,e

>

1- l4 i>;>

{ j. A. iRecoveryyan41ylis and it'orage'oficxklanthd nuclear.- pacem' a kers, ,

i

4 l

j ,

q, - -. _ _ - ',

-I carig1110m t

, q.

q>

! i 10, A,

'l t.icense material may.be used at the licensee's Rice Creek'facilit'y', N d

7000 Central Avenue:N L ,1 Minneapolis.. Minnesota, -

I I l' 2

l 8. Theflicensee is authorifed to storeLon'e; g ' generator;at each of,the licensee's,seven(1).Medtronic Model 9000 isotopic pulse?

t. lettersfdated SeptemberE8U1977, September. district offices in accordance with' ' ~

1 8, 1991. 27.-1977 M1une 26',~1985 arid Augusti'

I, Storage at district cffices'shall not exceed 30 days. ' '

) I 11 .

j i

f License material shall be used by, or under the supervision of, i F ll 12. h 1l, er Charles The RadiationSwanson.

Protection Officer for the activities authorized by this license is N I h d' 18 4:

l i

010 m.

I '

i' E COPY -

s == ==mmm ,= = = = = = = = = = = = = = = = = = == = = = = = = = == = =mvav=vomvou~

8 w=vmouvst g<(

= -

AWE *WWWWr3*&*A95."2.4WMs = = = = = -

l .my e.. M 4 _ =mmimiisauna www-umon<wunimm;;_ =mn-imwmum.mnn9 U 5 NUCE i AH HEGUL A1ORY COMMIS5K,N

"'**' g g_g 3 pgg,g _ f twenw numtm '

l I

M A f ERI ALS LICENSE sueett MrNT ARY SHE E T g,j%d --

)

l >

. _. 070:01209 . . _

{. .- . _ L.._ _ltpondment Rom.22.-.

('

. . . _ . _ . _ l i

l!

I q

A.

0l if13.

di (1) The source (s) specified in item (s) 7. A. shall be tested for leakage and/or l ti contamination at Intervals not to exceed 6 months. Any source received '

from another person which is not accompanied by a certificate indicating g

f that a test was performed within 6 months before the transfer shall not be flI  !

put into use until tested. g p1 l!

(

4 FI 4' (2) flotwithstanding the periodic leak test required by this condition, any l '

ii licensed sealed source is exempt from such leak tests when the source >l l b

contains 100 microcuries or less of beta and/or gamma emitting material or 10 ratrocuries or less of alpha emitting material. >{

q' B. Any source in storage and not being used need not be tested. When the source 4 F:

is reroved f rom storage for use or transfer to another person, it shall be >'

4 4

tested before use or transfer, l' '

3 h;F C.

The test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample, if the test reveals the presence of

'p*t 3

4, 0.005 microcurie or more of removable contamination, the source shall be ip

.I removed from service witt Com.ission regulations. and decontaminated, repaired, or disposed of in accordance l>

j A report shall be filed within 5 days of the date f the leak test result is known with the U.S. Nuclear Regulatory Commission, t

q i Region 111, 799 Roosevelt Road, Glen Ellyn, Illinois 60137, ATIN Chief, f'

( Nuclear Materials Safety Branch. The report shall specify the source involved. !pl ig,)

. (,

' the test results, and corrective action taken. Records of leak test results

d; Iki d

i shall be kept the Commission.

in units of microcuries and shall be maintained for inspection by >c 4 Records may be disposed of following Commission inspection. N kJ

)(

D.

Tests for leakage and/or contamination shall be performed by the licensee or by h other persons specifically, licensed by the Commission or an Agreement State to jpj 4 perform such services. -

i $j ,

I 14 Scaled sources containing licensed material shall not be opened.

>1 f f 4 15. Medtronic, Inc., shall collect, tally and submit a report annually to the U.S. $p 1

(

4 Nuclear Regulatory Commission, Region !!!, 799 Roosevelt Road, Glen Ellyn, Illinois by 4

60137, AITH: Chief, Nuclear Materials Safety and Safeguards Branch. The report F shall include data received from all investigators in accordance with the procedures b f described in pages 2 and 3 of "Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse f

4 Generator CLINICAL INVESilGATION PLAN" dated March 21, 1973.

I

(; 16.

f b

E The licensee may transport licensed material in accordance with the provisions of b, d;. 10 CFR Part 71, " Packaging and Transportation of Radioactive Material." >i d >

F 1l

< k 4 m

( ;F 4

4 ib:

q #

4: COPY $

$. s....,, l>L N

, C .

EYE M?.8!M!18'b"@_A k

,s nip re,,n 3:4 A U 5 NUCLE A% 0.EGUL Af 0RY COM8AISSION h

> ( *, s e s p q~

3' g'" 3 " p y,. , g ' p gg , ,,, ,,, g,7' llll M ATERIALS LICENSE SUPPLEMENT ARY SHEET g,,, dM,hh-- -- ---

l 070-01209 .- . _ _ . . _ _ .

p>

, h l

. _ - . . . . . . .__ _._ ._.. _. . . . ._ _ _. _. ___ Ane ndmen LH o . . 2 2 . . . . . . . _ . _ .

l' F, l

ki l-k.

4 i >'

17, Except for plutonium contained in a medical device designed for individual human >

4r application, no plutonium, regardless of form, shall be delivered to a carrier for >

j! shipment by air transport or transported in an aircraft by the licensee except in 4

i packages the design of which the NRC has specifically approved for transport of h

f. plutonium by air. -

i (!18.

4 The licensee shall maintain records of information important to safe and effective I'j I 4 decommissioning at the address specified 'irrlicense Item 2. per the provisions of bj lll 10 CFR 70.25(g) until this license is terminated by the (.ommission.

19. Except as specifically provided otherwise in this license, the licensee shall h conduct its program in accordance with the statements, representations, and >':

4 1

4l; procedures contained in the documents including any enclosures, listed below. lhe 3- 1 l Nuclear Regulatory Commission's regulations shall govern unless the statements, i

!Y representations and procedures in the licensco's application and correspondence are h more restrictive than the regulations.

h A. a Application dated August 7, 1969 and supplements dated May 26, 1970, il Gctober 23, 1970 May 14, 1971, August 18, 1971, Stptember 14, 1971, I

L ;l February 28, 1972, August 29,1972, March 5,1973, Man h 23, 1973, l!l' May 10, 1973, September 5, 1974. March 24, 1975 April 8, 1916, y October 7, 1976, February 10, 1977, September 8, 1977 and September 27, 1977; h L!

4 and y pl Al

-4l B. Letters dated June 26, 1985 (Renewal), May 21, 1986, Augu,t 8, 1991 and i>*g>

.% December 5, 1991. ,

3 N' >

9.

4 'Isl1,;

<  !"l k

4 ,bl 4

'4 ,

4 .

4.  ;>I b

(-

lp 4-

'l4 8,

FOR Till U.S. liUCll AR REGUL A10Rt LOMMISS10!1 >

F

' F, L

ip ,

/ /

, Date '//. /7 6 ' ' .> ,. d . . . -

+

l' ~ ByHaGFiali

' ~ ,[ [ fic'eniing Section ' Region

~

(%

. ) e

,' i i

k COPY

d(>

a

.,......:..,,,,vv.....,,,+,#.. . - . , , . . . . . t

f

,- l l

. 1

- 1 Medtronic, Inc.  !

ATTH: Ms. Jean M. Wenell l Monitor of Device Surveillance MAR 2 01989 Studies <f3 I 7000 Central Avenue, NE s, ,l Minneapolis, Minnesota 55432-3576

/ i

.(

Dear Ms. Wenell:

This is in reference to Medtronic's October 1988 Report on Model 9000 l nuclear-powered pacemakers (trarismitted by your November 1,1988 letter) and the february 2,1989 telephone Conversation between Tom Hawkinson of Medtronic's staf f and Gary Roles of the Nuclear Regulatory Cornmission's (HRC's) staff. Enclosed for your information is a copy of a document prepared by Mr. Roles sumarizing his discussions with nuclear pacemaker manufacturers.

We are concerned about the apparent discrepancies between Medtronic's October 1988 report and the information provided by Mr. Hawkinson. The report indicates that 658 units have been implanted. This total is the same value reported by Medtronic for some years. Mr. Hawkinson is reported to have stated that "about 1800" units have been implanted, a nurnber almost three times that given in Medtronic's most recent report. Mr. Roles was seeking this information in order to estimate the number of plutonium-238 pacers for which disposal in the United States will be needed, both in the short- and long-term.

Please explain this apparent discrepancy and provide clarifying information.

- If "about 1800" nuclear pacers have been implanted, please submit revised copies of your reports to NRC and explain why erroneous inform 6 tion has been provided to the NRC for a nunber of years. If only 658 units have been implanted, please explain how the 1800 unit value was obtained by Mr. Hawkinson.

Sincerely,

[

Patricia C. Yacca Cornmerical Section Medical, Academic and Comercial Use Safety Branch, IMNS

Enclosure:

As stated DISTRIBUTION w/ encl.

'I' NM55 R/F 'NRC File ~ Cent're IMAB R/f JHAustin MLamastra INNS Central File PCVacca BMallett, RIII MMcCann, Rill DSrenawski, R!ll GRoles, HMSS/LLWM JHickey Docket No. 70-01209 n . [

OFC:IMAit :IFAB :IMA  :  :  :

/

NAME:PCta a:ht :HLamastra :JHApstin :

bATEbb)h)b9 bbh b9 bb N b9 $

OFFICIAL RECORD COPY n,- ,f h >

J