Recall Z-1599-2010 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Advanced Neuromodulation Systems, Inc
Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
| Date | May 13, 2010 (initiated Apr 23, 2010) |
| Status | Terminated |
| Reason | Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability. |
| Root cause | Manufacturing material removal |
| Action | St. Jude Medical issued an "Important Medical Device Information" notification dated April 2010. Consignees were informed of the affected product and instructed on necessary steps. Any returned product should be sent to the firm. For further information, contact your St. Jude Medical Neuromodulation Division Sales Representative or call 1-972-309-2154. |
| Quantity | 7 devices |
| Distribution | Nationwide Distribution -- GA, NC, CA, OK, SC and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.