The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows

FDA device recall Z-2281-2012 · posted 2012-08-28 · Terminated

Recall details

Recalling firm

Advanced Neuromodulation Systems Inc.

Reason for recall

As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.

Action taken

ST. Jude Medical sent an Important Medical Device Correction letter dated December 19, 2011 to all affected customers. The letter identified the affected product, problem and recommendations to be followed. For questions contact your St. Jude Medical Neuromodulation Division Representative.

Root cause

Labeling design

Status

Terminated

Product code

LGW

Quantity affected

30,560 units

Distribution

Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Is

Date initiated

2011-12-19

Date posted

2012-08-28

Date terminated

2015-07-24

Location

Plano, TX