Reported Jul 18, 2012 · Terminated
Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic…
Advanced Neuromodulation Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Neuromodulation Systems Inc. · 6901 Preston Rd · Plano, TX · 75024-2508
Is this the product you have?
- 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 followingfailed back surgery syndrome, intractable low back and leg pain
- Lot codes and dates
- Model Number 3788. All lots manufactured prior to September 20, 2010.
- Amount recalled
- 25, 255 devices
Where it was sold
- Nationwide
- PR
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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