Recall Z-1983-2012 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Advanced Neuromodulation Systems Inc.
Eon Mini Neurostimulation (IPG) System (Model 3788); The product 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 | Jul 10, 2012 (initiated Dec 19, 2011) |
| Status | Terminated |
| Reason | The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin |
| Root cause | Process design |
| Action | St. Jude Medical sent an Important Medical Device Recall letter dated December 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were issued the following instructions: For unimplated inventory of affected product customers should contact their SJM Representative to have the device returned to St. Jude Medical. A replacement device will be provided at no additional cost to them. For implanted affected product it is recommended that customers do not unnecessarily explant the devices associated with this |
| Quantity | 25, 255 devices |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.