Class 2 Device Recall Eon Mini Neurostimulation (IPG) System

• Date Initiated by Firm: December 19, 2011
• Date Posted: July 10, 2012
• Recall Status: Terminated on July 24, 2015
• Recall Number: Z-1983-2012
• Recall Event ID: 61151
• PMA Number: P010032S023
• Product Classification: Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
• Product: 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.
• Code Information: Model Number 3788. All lots manufactured prior to September 20, 2010.
• 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: 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
• FDA Determined Cause: Process design
• Action: St. Jude Medical sent an Important Medical Device Recall letter dated December 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were issued the following instructions: For unimplated inventory of affected product customers should contact their SJM Representative to have the device returned to St. Jude Medical. A replacement device will be provided at no additional cost to them. For implanted affected product it is recommended that customers do not unnecessarily explant the devices associated with this advisory if the IPGs are functioning as intended. If there is a sudden loss of power or if the duration between recharges becomes significantly shorter, customers should contact their St. Jude Medical Representative. If device replacement is required due to IPG failure related to this voluntary recall notice, St. Jude Medical will provide a replacement IPG at no charge. For questions regarding this recall call 972-309-2154.
• Quantity in Commerce: 25, 255 devices
• Distribution: 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.
• 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 and Original Applicant = Abbott Medical