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U.S. Department of Health and Human Services

Class 2 Device Recall Eon Mini Charging System

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  Class 2 Device Recall Eon Mini Charging System see related information
Date Initiated by Firm July 26, 2012
Date Posted July 16, 2013
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Abbott Medical
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