Device product
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Z-0894-2013
Product summary
- Event
- Event 61554
- Status
- Terminated
- Classification
- Class II
- Quantity
- 388 units
- Official record key
device-enforcement:Z-0894-2013
Official wording
Reason: Unintended Fluid ingress into the device header has been shown.
Code information: Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.
Distribution pattern: Worldwide Distribution - 53 consignees out of the US.
Derived failure modes
-
Unknown
Unintended Fluid ingress into the device header has been shown.