Recall Z-0894-2013 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Advanced Neuromodulation Systems Inc.
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
| Date | Feb 28, 2013 (initiated Mar 28, 2012) |
| Status | Terminated |
| Reason | Unintended Fluid ingress into the device header has been shown. |
| Root cause | Device Design |
| Action | St. Jude Medical sent an Important Product Field Corrective Action Device Information letter dated March 28, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for any unused product, isolate the affected product for return to St. Jude Medical. Their local representatiave would collect the unused inventory. Any unused product would be replaced with product once inventory becomes available. For patients with implanted product and no degradation of therapy, it is rec |
| Quantity | 388 units |
| Distribution | Worldwide Distribution - 53 consignees out of the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.