Z-0025-2013 Class II Terminated
FDA device recall Z-0025-2013 was initiated by Advanced Neuromodulation Systems Inc. on September 4, 2012 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated May 12, 2014). Affected quantity: 56 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2012
- Initiation Date
- September 4, 2012
- Termination Date
- May 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 units
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.
Reason for Recall
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 Pattern
US Nationwide Distribution
Code Information
Eon Mini - 3788 (IPG), Multiple Serial Numbers