Recall Z-2281-2012— Advanced Neuromodulation Systems Inc.

Class II FDA medical device recall by Advanced Neuromodulation Systems Inc., initiated 2011-12-19, terminated 2015-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..

Recalling firm

Advanced Neuromodulation Systems Inc.

Classification

Class II

Status

Terminated

Initiated

2011-12-19

Terminated

2015-07-24

Firm location

Plano, TX, United States

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