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Terminated

Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are 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-2280-2012 · Posted 2012-08-28

Recalling FirmAdvanced Neuromodulation Systems Inc.
Recall StatusTerminated
Product CodeLGW
Date Initiated2011-12-19
Date Terminated2015-07-24
Product Quantity26,388 units

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.

Firm Action

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

Distribution Pattern

Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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