ML20153C993
| ML20153C993 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 07/21/1998 |
| From: | Swanson C MEDTRONIC, INC. |
| To: | Bhachu U NRC |
| Shared Package | |
| ML20153C940 | List: |
| References | |
| SSD, NUDOCS 9809240266 | |
| Download: ML20153C993 (4) | |
Text
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Medtronic, Ir=.
7000 Central Awnue N E, CBC T275 Minneapolis, MN $5432 Internet wwwmedtroniccom Tel: 612-5140409 Fax 612-514-6424 Charles H. Swanson chuckswanson@medtroniccorn Vce Presdont Ccrporate Regulatory Nfars 4
July 21,1998 Mr. Ujagar Bhachu Nuclear Regulatory Commission 2 White Flint North Mail Stop 8F5 11545 Rockville Pike Rockville, MD 20852 Phone: (301) 415-7894 RE: Nuclear Pacemaker License Number: SNM 115G
Dear Mr. Bhachu,
In response to your phone call of July 9, attached are the answers to the list ofitems that needed resolution before the license would be considered ' inactive'. Please feel free to give me a callif you need anything further.
Sincerely,
- 4 f314:
CHS:kls: 9807:40i Attachments CC:
Larry Paulson 9000 File 9809240266 980916 PDR RC SSD PDR
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ATTACHMENT A l
Open Issues
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License Number: SNM 115G Nuclear Pacemaker Model 9000 1.
What is the total number of product sold?
G55 devices sold How many units are stillir. use?
59 possible stillin use How many units are on the shelf?
None on shelf How many units have been returned?*
521 returned
- l How many units have been transferred?
None transferred
- 75 devices have been documented as no longer in use but not returned.
- 2. Who will service the pacers stillin use if the license becomes inactive? Physicians do the service / follow-up on the pacers now and we expect that would continue aslong as devices remain implanted. Explanted units are typically returned to Medtronic.
- 3. A statement that the holder of the license will no longer commercially distribute the product.
See Attachment B.
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- 4. A confirmation that there have been no changes since the last amendment (estimated 1990); or,if so, inclusion of any backup information on the changes made.
The changes to the last amendment (November,1997) are as follows:
59 possible unii3 still in use (G4 last report).
44 active confirmed last year 15 lost to follow up 521 devices returned to Medtronic (51G last report)
Next report is due in November,1998.
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- 5. A previous notation (Hawkins) states there was a dispute over the number of units sold. Include a statement stating the resolution of the dispute.
We have nothing in our files referencing a letter from Hawkins regarding a dispute over the number of units sold. However, as noted in the last report sent (November,1997 -
Attachment C), seven :levices were re implanted so that the number of patient implants is greater than the number of devices.
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ATTACHMENT B 4
CERTIFICATION STATEMENT I,
Charles H. Swanson, Vice President, Corporate Regulatory Affairs, do affirm that Medtronic ceased the sale and distribution of the Pacemaker Model 9000 in the 1970's.
July 20,1998
Attachmint C h lC S Medtronic, Inc.
7000 Central Avenue N.E.
Minneapolis. MN 55432-3576 Telephone:(612) 514-400o November 1,1997 Chief of Nuclear Materials Safety and Safeguards Branch U.S. Nuclear Regulatory Commission Region 111 801 Warrenville Road Lisle, IL 60532-4351 Attn: John A. Grobe, Chief
Dear Mr. Grobe:
Enclosed is a summary of the clinical evaluation study of the Medtronic Implantable Demand ISOTOPIC PULSE GENERATOR, Laurans-Alcatel Model 9000. The closing date for the data in this report is October 1,1997. Since the last years report many previous Lost-To-Follow-Up patients were successfully contacted and their status updated. (attachment I)
This report is submitted as an update of the Summary of Clinical Evaluation Study submitted to the United States Nuclear Regulatory Commission on November 1,1996.
If you have any questions regarding this report, please contact me at 1-800-328-2518 (x6232).
Sincerely, Medtronic, Inc.
C y-..-v W
Larry Paulson, P.E.
Post Market Surveillance Manager Clinical Operations
- jd cc: Patricia C. Vacca - NRC
('
l 1
MEDTRONIC IMPLANTABLE DEMAND ISOTOPIC PULSE GENERATOR
' LAURENS-ALCATEL MODEL 9000
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l.
SUMMARY
OF CLINICAL EVALUATION STUDY l
l Submitted to the UNITED STATES NUCLEAR l
REGULATORY COMMISSION l
l October,1997 L
1 1
s
'1 INTRODUCTION 1
Six hundred sixty-two (662) implants of Medtronic Model 9000 isotopic pulse generators, or nuclear-powered pacemakers have been recorded in the United States since 1972, according to reports submitted to Medtronic. Physicians and hospitals licensed to implant these devices have done so under a clinical investigation plan approved by the United States Nuclear Regulatory
. Commission.
The Model 9000 performance has been documented in twenty five (25) previous evaluation reports. Results conclusively demonstrated that the Model 9000 is at least as reliable as chemically-powered units. However, improved longevity of chemically-powered units, primarily lithium, have considerably decreased the need for a nuclear-powered unit. Therefore, Medtronic is no longer selling the Model 9000 pulse generator with a nuclear power source.
This summary documents the status of the Model 9000 pulse generator as of October 1997, and updates the previous summary of October,1996. It also clearly demonstrates that complete and continuous accountability for all nuclear devices will not be maintained.
Attachment 1.
Current status of the Model 9000 pulse generator.
II.
Explants not previously reported.
Ill.
Review of failures.
IV.
Statement of Model 9000 accountability.
4 Previous Reoorts Medtronic, Inc., Status Report No.1 of the Clinical study of the Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generator. Minneapolis, Unpublished Manuscript, November 20,1973.
~
Ibid., Status Report No. 2, June 28,1974 lbid., Status Report No. 3, November 24,1974 lbid., Status Report No. 4, May 24,1975 lbid., Status Report No. 5, November 24,1975 lbid., Status Report No. 6, May 24,1976 Medtronic Implantable Demand Isotopic Pulse Generator Laurens-Alcatel Model 9000, Summary of Clinical Evaluation Study. Minneapolis, Unpublished Manuscript, November 24, 1976 lbrJ., Summary No. 2, May 25,1977 lbid., Summary No. 3, May 26,1978 lbid., Summary No. 4, May 26,1979 lbid., Summary No. 5, December 15,1980 lbid., Summary No. 6, May 26,1981 lbid., Summary No. 7, June 25,1982 lbid., Summary No. 8, May,1983 lbid., Summary No, 9, September,1984 lbid., Summary No.10, October,-1987 lbid., Summary No.11, October,1988 Ibid., Summary No.12, October,1989 lbid., Summary No.13 October,1990 lbid., Summary No.14, October,1991 lbid., Summary No.15, October,1992 lbid., Summary No.16, October,1993 lbid., Summary No.17, October,1994
' lbid., Summary No.18, October,1995 lbid., Summary No.19 October,1996 0
ATI'ACHMENT I
~ 'CORRENT STATUS OF.THE MODEL 9000 PULSE GENERATOR l.
Implant Data A.
Total number ofimplants -
662 B.
Number of devices reimplanted -
7 C.
Total number of devices -
655 D.
- Active /potentially active status 1.
- Active status confirmed 48 (Recent follow-up reports, < 1 year) 2.
Lost-to-Follow-up 16 (No recent follow-up reports, > 1 year)
E.
Inactive Status (Reported out of service) 1.
Retumed to Medtronic-516:
2.
Patient death 40 (Device location unknown) 3.
Device explanted 20 (Device location unknown) 4.
Device buried with patient -
14 5.
Device buried in landfill-1
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l ATTACHMENT ll EXPLANTS NOT PREVIOUSLY REPORTED.
)
S/N PAT. CODE REASON FOR EXPLANT DATE OF STATUS OF IPG APPROXIRAATE EXPLANT.
PATIENT AGE AT t
DEATH, RETURN EXPLANT / DEATH j
3R00075 1085 PATIENT EXPIRED 02/19/97 RETURNED /OK 76 1
l 3R00116 1063 PATIENT EXPtRED 07/27/97 RETURNED /OK 77 1
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3R00149 1055 ELECTIVE 08/15/97 RETURNED /OK 82 1
REPLACEMENT 3R00155 1046 UNKNOWN REC'DBf RETURNED /OK 65 MEDTRONIC 5/14/97
+
i 4R00079 3228 BATTERY DEPLETION 2/20/97 RETURNED / CORRODED 60 INotCATED CONNECTOR BLOCK 4R00235 2622 BATTERY DEPLETION 1/22/97 RETURNED /OK 66 INDICATED SR00116 3206 UNKNOWN 2/13/97 RETURNED /OK 86 6R00377 2667 PATIENT EXPtRED 12/02/96 RETURNED /OK 65 m
UPDATE FROM 1996 REPORT 4R00316 3567 PATIENT EXP1 RED 5/15/96 RETURNED /NO OUTPUT 82 t
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ATTACHMENT lil 1
EXPLANATION OF MODEL 9000 FAILURES 4
' SINCE REPORT OF OCTOBER,1996 Two (2) failures have been identified (see Attachment II) since publication of the October,1996 summary. There have been a total of One Hundred Fifty-Three (153) failures since the unit was introduced in 1972.
J FAILURE NUMBER J
1 Corroded Connector Block 1
1 i
2 No Output 1
d ATTACHMENT IV STATEMENT OF MODEL 9000 ACCOUNTABILITY An objective of the Model 9000 investigational Program has been to evaluate the system of patient registration, follow-up and recovery of the pulse generator. Difficulties in maintaining complete patient follow-up have been reported previously. Continued reliance has had to be placed on follow-up information obtained by telephone and Medtronic Retumed Product Department since routine data forms are often not retumed to Medtronic per the protocol agreement. Therefore, in spite of efforts by Medtronic, total and continuous accountability for the status of all patients with Model 9000 pulse generators cannot be maintained. However, l
retum of explanted devices to Medtronic is likely.
O 1
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PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMMISSION pes)
REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send tNs request AND a copy of all related letters /apphcations and drawinge to: The Sealed Source Safety Section, ATTN: CNef, OWFN Mail Stop 6 H3 Change the Ucense Tracidng Systern rnilestone to 19 and assign to reviewer code I-5.
NOTE: Retain a copy of this request with the application and background flies.
REQUEspt REGION / LOCATION:
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f TELEPHONIE AUMBER DATE TYPE OF LTION REQUESTED (Check es appropriate)
APPLEANTS NAME SOURCE REVIEW AMENDMENT OF REGISTRATION SHEET huWL CONTROL NUMBER (S)
DEVICE REVIEW NUMBER (S)
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LETTER /
TON LICENSE NUMBER (S)
CUSTOM REVIEW
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no cwme me, u e.
NiAINGAj 0Li5, Fl/V 55'/3s2 0
FOR SSSS USE ONLY REVIEWER MODEL NUMBERS NUMBER ASS 90NED
/su" oATE RECEivEo oArE AssoNEo oATETo FEuS
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TYPE OF ACTION (Indicate the number of each type) 4_.
l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C)
DEVsCE (9A)
SOURCE (90)
DEVICE (98)
NEW NEW NEW NEW
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AMENDMENT
[ AMENDMENT
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AMENDMENT
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AMENDMENT
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dNO SAFETY EVALUATION REQU; RED j UCENSING ACTION REQUIRED IF KNOWN NO
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NO FEES REQUIRED j OTHER (SpeciVP)
TOTAL NUntBER OF NOT S g
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- REVIEW HC URS NUMBER OF
/f)d Q / [6 DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY NEW REGISMON -
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NAME CHANGE ADDRES!! CHANGE ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY d
l9A 98 9C 90 AMOUNT RECEIVED CHECK NUMBER MATANN UPDATED g
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DATE OF CHECK y [ 784 W/,)
J MATSYS UPDATED s
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