ML20198B425
| ML20198B425 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 10/31/1998 |
| From: | MEDTRONIC, INC. |
| To: | |
| Shared Package | |
| ML20198B400 | List: |
| References | |
| NUDOCS 9812180163 | |
| Download: ML20198B425 (7) | |
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MEDTRONIC IMPLANTABLE DEMAND ISOTOPIC PULSE GENERATOR LAURENS-ALCATEL MODEL 9000
SUMMARY
OF CLINICAL EVALUATION STUDY i
Submitted to the UNITED STATES NUCLEAR REGULATORY COMMISSION l
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October,1998 i
L 9812180163 981101 PDR ADOCK 07001209 i
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INTRODUCTION Six hundred sixty-two (662) implants of Medtronic Model 9000 isotopic pulse generators, or j
nuclear-powered pacemakers have been recorded in the United States since 1972, according to l
reports submitted to Medtronic. Physicians and hospitals licensed to implant these devices have i
done so under a clinical investigation plan approved by the United States Nuclear Regulatory Commission.
The Model 9000 performance has been documented in twenty six (26) 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.
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This summan/ ocuments the status of the Model 9000 pulse generator as of October 1998, and d
l updates the previous summary of October,1997. It also clearly demonstrates that complete and continuous accountability for all nuclear devices will not be maintained.
Attachment I.
Current status of the Model 9000 pulse generator.
11.
Explants not previously reported.
Ill.
Review of failures.
IV.
Statement of Model 9000 accountability.
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Previous Reports 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 Minneapolis, Unpublished Manuscript, November 20,1973.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 Ibid., Status Report No. 4, May 24,1975 3
lbid., Status Report No. 5, November 24,1975 lbid., Status Report No. 6, May 24,1976 l
Medtronic Implantable Demand Isotopic Pulse Generator Laurens-Alcatel Model 9000, Summary of Clinical Evaluation Study. Minneapolis, Unpublished Manuscript, November 24, i-1976 lbid., 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 l
- Ibid., 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
! bid., Summary No.18, October,1995 lbid., Summary No.19, October,1996 lbid., Summary No. 20, October,1997 i
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ATTACHMENT I l
CURRENT STATUS OF THE MODEL 9000 PULSE GENERATOR I.
Implant Data A.
Total number of implants -
662' B.
Number of devices reimplanted -
7 C.
Total number of devices -
655 D.
' Active /potentially active status 1.
Active status confirmed 43 (Recent follow-up reports)
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Lost-to-Follow-up 14 (No recent follow-up reports)
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Inactive Status (Reported out of service) 1.
Returned to Medtronic -
523 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 i
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ATTACHMENT 11 EXPLANTS NOT PREVIOUSLY REPORTED S/N PAT. CODE REASON FOR EXPLANT DATE OF STATUS OF lPG APPROXIMATE l
- EXPLANT, PATIENT AGE AT l
DEATH, RETURN EXPLANT / DEATH f
3R00235 1026 UNKNOWN REC'D BY RETURNED /OK 77 MEDTRONIC 5/21/98 3R00278 1409 UNKNOWN REC'D BY ANALYSIS NOT YET 52 i
MEDTRONIC COMPLETED d
6/12/98
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I 3R00292 1161 BATTERY DEPLETION REC'D BY RETURNED /OK 71 t
INDICATED MEDTRONIC 5/21/98 4R00020 1380 PATIENT EXPIRED REC'D BY RETURNED /OK 79 MEDTRONIC 3/10/98 4R00047 1348 UNKNOWN REC'D BY A MALYSIS NOT YET 55 l
MEDTRONIC COMPLETED 8/27/98 4R00102 2747 PATIENT EXPIRED 2/7/98 RETURNED /OK 75 5R00003 3072 UNKNOWN REC'D BY RETURNED /OK 49 MEDTRONIC 3/10/98 I
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EXPLANATION OF MODEL 9000 FAILURES SINCE REPORT OF OCTOBER,1997 l-No additional failures have been identified (see Attachment II) since publication of the October, j
1997 summary. There have been a total of One Hundred fifty-three (153) failures since the unit 1
was introduced in 1972.
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ATTACHMENT IV t
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l STATEMENT OF MODEL 9000 ACCOUNTABILITY i
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 ir, 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 Returned Product Department since routine data forms are often not returned 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, return of explanted devices to Medtronic is likely.
Medtronic is aware of the April 3,1998 NRC Information Notice 98-12:
Licensees' Responsibilities Regarding Reporting and Follow-up Requirements for Nuclear Powered Pacemakers. We believe we have made reasonable efforts to meet our licensing commitments.
However, as indicated above, our experience demonstrates that maintaining 100% patient follow-up after more than 25 years is not possible.
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DATE:
CORRESPONDENCE CLARIFICATION SHEET L
REVIEWER:
MONTE PHILLIPS/ SANDY FRAZIER LICENSEE:
MdTTM/I'G dA//A'//8[j 70 'O/A07 LICENSE NUMBER:
The following correspondence has been received from the above licensee and it is not clear what action (s) is(are) required:
Please review this corresx>ndence and indicate which of the following applies, and please return l
to Deb)ie Hersey, or Ryan Te. as soon as possible.
Additional Information to Control No.
Process in as a new action, additional information, and no fee required.
Process as new licensing action. Review has already been started on Control No, and this information cannot be combined with current in house action.
'Can be combined with Control No.
. Review has not started.
fAppears to be information for the license file file J
Licensee is adding Nuclear Pharmacists.
Amendment is necessary Amendment is not necessary (Information for license file)
Licensee is adding authorized users.
l A check is included No check is included l
Amendment is necessary Amendment is not necessary l
(This is a Notification) l Process in as a new licensing action:
t A.
Amendment B.
Renewal C.
New License Application Other:
Thank You For Your Help!!!
01/28/98 l
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