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U.S. Department of Health and Human Services

Class 2 Device Recall DBS Pocket Adaptor

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  Class 2 Device Recall DBS Pocket Adaptor see related information
Date Initiated by Firm June 23, 2016
Create Date August 24, 2016
Recall Status1 Terminated 3 on September 21, 2017
Recall Number Z-2645-2016
Recall Event ID 74552
PMA Number P960009 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Product DBS Pocket Adaptor, Model 64001 and Model 64002.

The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.
Code Information Notification is not lot specific.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave
Minneapolis MN 55421-1241
For Additional Information Contact
800-707-0933
Manufacturer Reason
for Recall		 Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were sent on 6/23/2016 a "Medical Device Safety Notification," dated June 2016. The letter was addressed to Healthcare Professional. The letter described "Background" information on the problem and product involved in the recall. It also provided "Recommendations" which included "Implanting the pocket adaptor with the neurostimulator" and "Checking system integrity". For questions contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - 6pm CST.
Quantity in Commerce 7,542 in the US and 12,999 outside the US.
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MHY and Original Applicant = MEDTRONIC Inc.
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