Class 2 Device Recall Eon Mini Charging System

• Date Initiated by Firm: July 26, 2012
• Date Posted: July 16, 2013
• Recall Status: Terminated on November 18, 2015
• Recall Number: Z-1739-2013
• Recall Event ID: 63109
• PMA Number: P010032S028
• Product Classification: Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
• Product: 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.
• Code Information: All serial numbers manufactured
• Recalling Firm/ Manufacturer: St. Jude Medical; 6901 Preston Rd; Plano TX 75024-2508
• For Additional Information Contact: 972-309-2154
• Manufacturer Reason for Recall: 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
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LGW