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.
FDA Recall Z-0025-2013 · Posted 2012-10-09
Advertisement
Recalling FirmAdvanced Neuromodulation Systems Inc.
Recall StatusTerminated
Product CodeLGW
Date Initiated2012-09-04
Date Terminated2014-05-12
Product Quantity56 units
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.
Firm Action
ST. Jude Medical sent an important Medical Device Advisory letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem and recommended actions to be taken. For questions contact your St. Jude Medical Neuromodulation Division Representative or call the Technical Services Department at 1-800-727-7846.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement