ML20199A833
| ML20199A833 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 11/01/1997 |
| From: | Paulson L MEDTRONIC, INC. |
| To: | Grobe J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| References | |
| NR-8104-D-801-S, SSD-98-63, NUDOCS 9711180125 | |
| Download: ML20199A833 (9) | |
Text
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f MMNh Medtroric, Inc.
7000 Central Avenue N.E.
%nneapolis. MN 55432-3576 Telephone: (612) 514-4000 d'y\\lyb November 1,1997 f
-D' Chief of Nuclear Materials Safety and Safeguards Branch U.S. Nuclear Regulatory Commission Region ill 801 Warrenville Road Lisle, IL 60532-4351 Attn: John A. Grobe, Chief
Dear Mr. Grobo:
Enclosed is a summary of the clinical evaluation study of the Medtronic Irnplantable Demand ISOTOPIC PULSE GENERATOR, Laurens 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.
V Lany Paulson, P.E.
Post Market Surveillance Manager Clinical Operations RECEIVED
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MEDTRONIC IMPLANTABLE DEMAND L
ISOTOPIC PULSE GENERATOR
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LAURENS-ALCATEL MODEL 9000 z
SUMMARY
OF CLINICAL EVALUATIO' ~ STUDY i-L k
Submitted to the UNITED STATES NUCLEAR REGULATOR'y COMMISSION
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L October,1997 s
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'NTRODUCTION Six hundred sixty-two (662) implants of Medtronic Model 9000 isotopic pulse generators, or h
nuclear-powered pacemakers have been recorded in the United States since 1972, according to rerjorts submitted to Medtronic. Physicians and hospitals licensed to implant these devices have dane 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
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reports. Results conclusively demonstrated that the Model 9000 is at least es reliable as a
chemically-powered units. However, improved longevity of chemically-powered units, primarily J
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 4
1.
Current status of the Model 9000 pulse generator.
II.
Explants not previously reported.
j 111.
Review of failures.
t' 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 lbid., Status Report No. 4, May 24,1975 lbid., Status Report No. 5, November 24,1975 lbid., Status Report No. O, May 24,1976 Medtronic Implantable Demand Isotopic Pulse Generator Laurens-Ancatel Model 6000, Summary of Clinical Evaluation Study. Minneapolis, Unpublished Manuscript, November 24, 1976 lbid., Summary No. 2, May 25,1977 lbid., Summary No. 2. May 26,1978 lbid., Summary No. 4, May 26.1979 lbid., Summary No. 5, December 15,1980 l bid., 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 lbid, 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
' bid., Summary No.19, October,1996
O O
s ATTACHMENTI-CURRENT 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,51 year) 2.
Lost-to-Follow-up 16 (No recent follow-up reports, > 1 year)
G.
Inactive Status (Reported out of service) 1.
Returned 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 L
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O ATTACHMENT ll EXPL ANTS NOT PREVIOUSLY REPORTED S/N PAT. CODE REASON FOR EXPLANT DATE OF STATUS OF IPO APPROXIMATE EXPLANT.
PATIENT AGE AT DEATH, RETURN EXP) ANT / DEATH 3R00075 1085 PAllENT EXPIRED 02/19/97 RETURNED /OK 76 3R00116 1063 PATIENT LXPIRED 07/27/97 RETURNED /OK 77 3R00149 1055 ELECTIVE 08/15/97 RETURNED /OK 82 REPLACEMENT 3R00155 1046 UNKNOWN REC'D BY RETURNED /OK 6b MEDTRONIC 5/14/97 4R00079 3228 BATTERY DEPLETION 2/20/97 RETURNEb/ CORRODED 60 INDICATED CCNNECTORBLOCK 4R00235 2622 BATTERY DEPLETION 1/22/97 RETURNED /OK 66 g
INDICATED 5R00116 J206 UNKNOWN 2/1'3/97 RE (URNED/OK 86 1
6R00377 2067 PATIENT EXPIRED 12/02/96 RETURNED /OK 65 UPDATE FROM 1996 REPORT 4R00316 3b67 PATIENT EXPIREL/
5/15/96 RETURNED /NO OUTPUT 82 v
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ATTACHMENT lli EXPLANATION OF MODEL 9000 FAILURES 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.
FAILURE NUMBER Corroded Connector Block 1
No Output 1
4
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ATTACHMENT IV STATEMENT OF MODEL 9000 ACCOUNTABILITY An objective of the Model 9000 investigational Program has seen 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 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, retum of explanted devices to Medtronic is likely.
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/!'b~N DATE:
CORRESPONDENCE CLARIFICATION SHEET REVIEWER:
--BJ HOLT-A746 /CN LICENSEE:
/77 M s LICENSE NUMBER:
$////7 -//84, The'fo110 wing correspondence has been received from the abose 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 conbined 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 Other:
Thank You For Your Help!!!
10/16/96 i