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Terminated

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.

FDA Recall Z-2645-2016 · Posted None

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeMHY
Date Initiated2016-06-23
Date Terminated2017-09-21
Product Quantity7,542 in the US and 12,999 outside the US.

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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