Class 2 Device Recall Eon Mini

• Date Initiated by Firm: December 19, 2011
• Date Posted: August 28, 2012
• Recall Status: Terminated on July 24, 2015
• Recall Number: Z-2281-2012
• Recall Event ID: 61171
• PMA Number: P010032S023
• Product Classification: Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
• Product: 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.
• Code Information: All lots of Eon Mini (Product Code 65-3788)
• Recalling Firm/ Manufacturer: Advanced Neuromodulation Systems Inc.; 6901 Preston Rd; Plano TX 75024-2508
• For Additional Information Contact: Steven Robertson; 972-309-2154
• Manufacturer 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.
• FDA Determined Cause: Labeling design
• 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.
• Quantity in Commerce: 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, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LGW