Home / Recalls / Advanced Neuromodulation Systems Inc. / Z-2281-2012

Z-2281-2012 Class II Terminated

Recalled by Advanced Neuromodulation Systems Inc. — Plano, TX

FDA device recall Z-2281-2012 was initiated by Advanced Neuromodulation Systems Inc. on December 19, 2011 and is designated Class II. 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 s… The recall status is terminated (terminated July 24, 2015). Affected quantity: 30,560 units.

Recall Details

Product Type: Devices
Report Date: September 5, 2012
Initiation Date: December 19, 2011
Termination Date: July 24, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 30,560 units

Product Description

The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. 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.

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.

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.

Code Information

All lots of Eon Mini (Product Code 65-3788)

Other recalls by Advanced Neuromodulation Systems Inc.

Z-0025-2013 Class II — The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, mu (September 4, 2012)
Z-0894-2013 Class II — Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, I (March 28, 2012)
Z-1983-2012 Class II — Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated (December 19, 2011)
Z-2280-2012 Class II — Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connec (December 19, 2011)