Recall Z-2607-2011 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Advanced Neuromodulation Systems Inc.
Eon Mini Neurostimulation (IPG) System Model 3788 System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
| Date | Jun 22, 2011 (initiated May 24, 2011) |
| Status | Terminated |
| Reason | Defective battery was identified as cause for reports of inability to communicate or recharge the product. |
| Root cause | Process control |
| Action | St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers. St. Jude Medical recommends no action be taken if the product serial numbers do not match the numbers listed in the letter. For product remaining in unimplanted inventory, customers are instructed to contact their SJM representative so that product may be returned and replacements be provided. For implanted product that matches the serial numbers, the Medical Advisory Board recommend not to unneces |
| Quantity | 17,141 |
| Distribution | Worldwide Distribution-- USA (nationwide) including PUERTO RICO and countries of AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, FINLAND,FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, SAUDI ARABIA, SINGAPORE, SOUTH A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.