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U.S. Department of Health and Human Services

Class 2 Device Recall Eon and Eon Mini

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 Class 2 Recall
Eon and Eon Mini
see related information
Date Posted July 22, 2013
Recall Status1 Open
Recall Number Z-1785-2013
Recall Event ID 63947
Premarket Approval
PMA Numbers
P010032 P010032/S028
Product Classification Stimulator, Spinal-Cord, Totally Implanted For Pain Relief - Product Code LGW
Product Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger (3701) provides the capability to recharge the IPG Battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The Eon Portable Charger (3711) provides the capability to recharge the IPG battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The patient can be mobile during the recharging process with a portable charger. The Eon Mini Charger (3721) provides the capability to recharge the IPG battery while stimulation is either on or off. The charger transmits RF energy through the antenna to the IPG battery to recharge it.
Code Information All serial numbers manufactured
Recalling Firm/
Manufacturer
St. Jude Medical
6901 Preston Rd
Plano, Texas 75024-2508
Manufacturer Reason
for Recall
There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the
FDA Determined
Cause 2
DESIGN: Device Design
Action St Jude Medical sent an Important Medical Device Safety Information letter dated November 30, 2012 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a replacement charger for the Eon Mini IPGs is now available and will be provided at no charge. For questions or concerns call St. Jude Medical at 877-650-0367.
Quantity in Commerce 75,663
Distribution Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Mexico, Netherlands, Poland, Russian Federal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LGW and Applicant = ADVANCED NEUROMODULATION SYSTEM,INC
PMAs with Product Code = LGW and Applicant = ADVANCED NEUROMODULATION SYSTEMS (ANS)
PMAs with Product Code = LGW and Applicant = ST. JUDE MEDICAL
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