Recall record at a glance
| Official record | Z-0025-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Advanced Neuromodulation Systems Inc. |
| Report date | Oct 17, 2012 |
| Recall initiation date | Sep 4, 2012 |
| Quantity | 56 units |
| Location | Plano, TX, United States |
Official product description
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.
Why the product 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.
Distribution information
US Nationwide Distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.