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Z-1983-2012 Class II Terminated

Recalled by Advanced Neuromodulation Systems Inc. — Plano, TX

FDA device recall Z-1983-2012 was initiated by Advanced Neuromodulation Systems Inc. on December 19, 2011 and is designated Class II. Reason for recall: The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm… The recall status is terminated (terminated July 24, 2015). Affected quantity: 25, 255 devices.

Recall Details

Product Type: Devices
Report Date: July 18, 2012
Initiation Date: December 19, 2011
Termination Date: July 24, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 25, 255 devices

Product Description

Eon Mini Neurostimulation (IPG) System (Model 3788); The product 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

The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Code Information

Model Number 3788. All lots manufactured prior to September 20, 2010.

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-2281-2012 Class II — The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, recharg (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)