| | Class 2 Recall
Brio DBS System |  |
| Date Posted |
February 28, 2013 |
| Recall Number |
Z-0894-2013 |
| Product |
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator. |
| Code Information |
Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.
|
Recalling Firm/
Manufacturer |
Advanced Neuromodulation Systems Inc.
6901 Preston Rd
Plano, Texas 75024-2508 |
| For Additional Information Contact |
Local SJM Representative
972-309-2154
|
Reason for
Recall |
Unintended Fluid ingress into the device header has been shown.
|
| 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 recommended dthat the devices not be unnecesssarily explanted. For patient with implanted product who experience diminished or loss of therapy customers were advised to follow the steps provided in the letter. Customers were asked to forward the notification to any institution in the event one or more patients or products could be potentially affected by this action. Customers wsere asked to maintain a record of thenotice along with the recommendations to ensure the effectiveness of the communication.
For questions regarding this recall call 972-309-2154. |
| Quantity in Commerce |
388 units |
| Distribution |
Worldwide Distribution - 53 consignees out of the US. |
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