Recall Z-1739-2013 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
St. Jude Medical
Eon Mini - 3721 (Charger). Product Usage: Eon Mini 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 | Jul 16, 2013 (initiated Jul 26, 2012) |
| Status | Terminated |
| Reason | St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica |
| Root cause | Device Design |
| Action | ST. Jude Medical sent an Important Medical Device Safety Information dated July 26, 2012 to affected customers. The letter identifed the affected product, problem and actions to be taken. For questions or concerns contact your ST. Jude Medical representative or St. Jude Medical Neuromodulation Division at 1-866-240-6741. |
| Quantity | 70,638 (combined total of the Eon and the Eon Mini systems) |
| Distribution | Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.