Recall Z-1983-2012— Advanced Neuromodulation Systems Inc.
Class II · Terminated
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: Eon Mini Neurostimulation (IPG) System (Model 3788); The product 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: The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin.
- 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
Product description
Eon Mini Neurostimulation (IPG) System (Model 3788); The product 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 for recall
The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin
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