Recall Z-2280-2012— Advanced Neuromodulation Systems Inc.
Class II · Terminated
Class II FDA medical device recall by Advanced Neuromodulation Systems Inc., initiated 2011-12-19, terminated 2015-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Advanced Neuromodulation Systems Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-12-19
- Terminated
- 2015-07-24
- Firm location
- Plano, TX, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.