Reported Oct 17, 2012 · Terminated
The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the…
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?
- 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 UsageEon 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 followingfailed back surgery syndrome, intractable low back and leg pain
- Lot codes and dates
- Eon Mini - 3788 (IPG), Multiple Serial Numbers
- Amount recalled
- 56 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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