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.
Enforcement
- Recall Number
- Z-2645-2016
- Event ID
- 74552
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Neuromodulation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 31, 2016
- Initiation Date
- June 23, 2016
- Classification Date
- August 24, 2016
- Termination Date
- September 21, 2017
- Address
- 7000 Central Ave, Minneapolis, MN, 55421-1241, United States
Description
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.
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.
Notification is not lot specific.
Worldwide Distribution.
7,542 in the US and 12,999 outside the US.