FDAFDA · Food and drugs·Recall number Z-0025-2013
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.
Published October 17, 2012 · Recall initiated: September 4, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Neuromodulation Systems Inc.
- Distributor
- US Nationwide Distribution
- Lot
- Eon Mini - 3788 (IPG), Multiple Serial Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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