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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are 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.
Recall Number Z-2281-2012
Classification Class II
Code Info All lots of Eon Mini (Product Code 65-3788)
Product Distributed Qty 30,560 units
Reason For Recall As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.

Event Detail

Event Id 61171
Product Type Devices
Status Ongoing
Recalling Firm Advanced Neuromodulation Systems Inc.
City Plano
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-12-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.