—#147891

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.

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960009
Affected lot / code info: Notification is not lot specific.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave, Minneapolis, Minnesota 55421-1241

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2016-06-23
Terminated: 2017-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147891. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.