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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description 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.
Recall Number Z-1785-2013
Classification Class II
Code Info All serial numbers manufactured
Product Distributed Qty 75,663
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 skin. This field action is to announce the availability of the newly designed Eon Mini Charger Model 3722 to mitigate excessive heating while charging.

Event Detail

Event Id 63947
Product Type Devices
Status Ongoing
Recalling Firm St. Jude Medical
City Plano
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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