Device 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.
Z-2645-2016
Product summary
- Event
- Event 74552
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,542 in the US and 12,999 outside the US.
- Official record key
device-enforcement:Z-2645-2016
Official wording
Reason: 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.
Code information: Notification is not lot specific.
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
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.