Recall Z-0396-05 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Advanced Bionics Corporation
Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
| Date | Jan 15, 2005 (initiated Nov 11, 2004) |
| Status | Terminated |
| Reason | A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit. |
| Root cause | Other |
| Action | Firm has notified all consignees and thier clinicians to provide them with the labeling addenda. Patient notices were sent by FedEx or by US Mail and clinicians were faxed the notice. |
| Quantity | 237 patients are implanted. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.