ML20134K851
| ML20134K851 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 10/31/1996 |
| From: | MEDTRONIC, INC. |
| To: | |
| Shared Package | |
| ML20134K830 | List: |
| References | |
| NUDOCS 9611200061 | |
| Download: ML20134K851 (9) | |
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MEDTRONIC IMPLANTABLE DEMAND ISOTOPIC PULSE GENERATOR LAURENS-ALCATEL MODEL 9000
SUMMARY
OF CLINICAL EVALUATION STUDY l
Submitted to the UNITED STATES NUCLEAR REGULATORY COMMISSION October, 1996 9611200061 961101 PDR ADOCK 07001209 C
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i-i T-i INTRODUCTION 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 j
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.
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.The Model 9000 performance has. been documented in twenty four (24)
. previous. evaluation reports.
Results-conclusively demonstrated that the Model 9000-is at least as reliable as chemically-powered units.
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- 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, 1996, and updates the previous summary of October, 1995. It
~ also clearly demonstrates that complete and continuous accountability for all nuclear devices will not be maintained.
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-l Attachment-
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I.
Current status'of the Model 9000 pulse generator.
-- I I.
Explants'not previously reported.
-III. Review of failures.
IV.
Statement of Model 9000 accountability.
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Previous Reports 4
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Minneapolis, Unpublished Manuscript, November 20, 1973.
4
' Ibid., Status Report No. 2, June 28, 1974 Ibid., Status Report No. 3, November 24, 1974 Ibid., Status Report No.
4, May 24, 1975 Ibid., Status Report No. 5, November 24, 1975
' Ibid., 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 Ibid., Summary No.
2, May 25, 1977 3
Ibid., Summary No.
3, May 26, 1978 Ibid., Summary No.
4, May 26, 1979 Ibid., Summary No.
5, December 15, 1980 Ibid., Summary No.
6, May 26, 1981 Ibid., Summary No.
7, June 25, 1982' Ibid., Summary No.
8, May, 1983 Ibid., Summary No.
9, September, 1984
. Ibid., Summary No. 10, October, 1987 Ibid., Summary No. 11, October, 1988 Ibid., Summary No. 12, October, 1989
. Ibid., Summary No. 13, October, 1990 Ibid., Summary No. 14, October, 1991
' Ibid., Summary No. 15, October, 1992
. Ibid., Summary No. 16, October, 1993 Ibid., Summary No. 17, October, 1994 Ibid., Summary No. 18, October, 1995 l
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ATTACHMENT I CURRENT STATUS OF THE MODEL 9000 PULSE GENERATOR I.
Impluis. 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 6
(Recent follow-up reports, -' 1 year) f 2.
Lost-to-Follow-up 73 (No recent follow-up reports, > 1 year) i E.
Inactive Status (Reported out of service)'
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Returned to Medtronic -
508 2.
Patient death 35 (Device location unknown) 3.
Device explantel 18 (Device location unknown) 4.
Device buried with patient -
14 5.
Device buried in landfill -
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A ATTACHMENT ll EXPLANTS NOT PREVIOUSLY REPORTED S/N HOSPITAL MD. CODE PAT CODE REASON FOR EXPLANT DATE OF STATUS OF iPG APPROXIMATE CODE
- EXPLANT, PATIENT AGE AT DEATH, RETURN EXPLANT /bCATH 3R00008 2003 2004 1029 UNKNOWN 3/29/96 RETURNED /OK 75 3R00020 20F 2004 1160 PATIENT EXPIRED 3/25/96 RETURNED /OK 80 3RD0055 1060 1006 1318 PROGRAMMING 3/5/96 RETURNED /
68 PROBLEM CORRODED CONNECTOR BLOCK 3R00109 1019 1021 1010 UNKNOWN REC'D BY RETURNED /OK 78 MEDTRONIC 9/23/96 4R00211 1013 1014 2625 MEDICAL JUDGEMENT /
1/17/96 RETURNED /OK 64 SYSTEM UPGRADE 4R00292 1027 2147 2980 CAPTURE AND SENSING 2/28/96 RETURNED /OK 70 DIFFICULTY 4R00316 1017 1019 3567 PATIENT EXPIRED 5/15/96 ANALYSIS STILL 82 IN PROGRESS 6R00307 3159 3196 3554 UNKNOWN REC D BY RETURNED /OK 62
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MEDTRONIC 10/5/95 i
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4 ATTACHMENT III EXPLANATION OF MODEL 9000 FAILURES SINCE REPORT OF OCTOBER, 1995 One (1) failure has been d.dentified (see Attachment II) since
-1 publication of the Oc'_ober, 1995 summary.
There have been.a total of One Hundred Fif ty-O:te (151) failures since the unit was introduced in 1972.
FAILURE NUMBER Corroded Connector Block 1
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l ATTACHMENT IV i
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 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.
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Medtronic, Inc.
Medtronic'f!
7000 Centrei nvenue. n s.
Minneapolis, MN 55432 3576 Telephone. (612) 574 4000 Cable: Mc~tronic Telex: 29 0598 Telecopy: (612) 574 4879 4
Nove r1 1991 United StatesJN'uclear: Regulatiory J Commissiori,g%, _
i iMedical,oAcademic HandaCommercialaUse; Safety, Branch 3
Division'of Industrial 1and-Medical _NucleariSafety m
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l Wash'ington, U D J C.s 120555?
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. ATTN: [ Q icia;C.tVa j
D Ms.
a sed s a summary of the clinical ev ation study of the Mcdt oni ant ble Demand ISOTOPIC P E GENERATOR, Laurens-Alcat 1 Model 9 0.
The closing date r the data in this report is Oct ber 1, 991.
-This re o is submitted as a update of the Summary of Clinical Evaluat n Study submitted t the United States Nuclear Regulatory Commi o
on. November 1, 990.
If ou any questi s regarding this report, please contact me at 00-32 -2 18 (
232).
Thank you.
Sincerely, MEDTRON C, C.
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Lar Pa n,
.E.
reduct Perfhrmance Engineer Se or C inical Operations \\
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f f-~ b-DATE:
CORRESPONDENCE CLARIFICATION SHEET
)
REVIEWER:
BJ HOLT LICENSEE:
MWKON[C >
LICENSE NUMBER:
b NM '// N The following correspondence has been received from the above licensee and it is not clear what action (s) is(are) required: Please review this corresmndence and indicate which of the following applies, and please return to Debaie Hersey, 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.
Appears to be information for the license file file it.[
Licensee is adding Nuclear Pharmacists.
Amendment is necessary
. Amendment is not necessary (Information for license file)
Licensee is adding authorized users.
A check is included No check is included Amendment is necessary Amendment is not necessary (This is a Notification)
Process in as a new licensing action:
A.
Amendment B.
Renewal C.
New License Application b d+-> * /b OL NMA
/,
her:
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i Thank You For Your Help!!!
10/16/96 J