Recall Z-0025-2013— Advanced Neuromodulation Systems Inc.

Class II FDA medical device recall by Advanced Neuromodulation Systems Inc., initiated 2012-09-04, terminated 2014-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. 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.. Reason: Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board..

Recalling firm

Advanced Neuromodulation Systems Inc.

Classification

Class II

Status

Terminated

Initiated

2012-09-04

Terminated

2014-05-12

Firm location

Plano, TX, United States

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