Class 2 Device Recall Eon Mini 3788 (IPG)

• Date Initiated by Firm: September 04, 2012
• Date Posted: October 09, 2012
• Recall Status: Terminated on May 12, 2014
• Recall Number: Z-0025-2013
• Recall Event ID: 63154
• PMA Number: P010032
• Product Classification: Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
• Product: The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system 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: Eon Mini - 3788 (IPG), Multiple Serial Numbers
• Recalling Firm/ Manufacturer: Advanced Neuromodulation Systems Inc.; 6901 Preston Rd; Plano TX 75024-2508
• For Additional Information Contact: Technical Services Department ; 800-727-7846
• Manufacturer Reason for Recall: Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.
• FDA Determined Cause: Nonconforming Material/Component
• Action: ST. Jude Medical sent an important Medical Device Advisory letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem and recommended actions to be taken. For questions contact your St. Jude Medical Neuromodulation Division Representative or call the Technical Services Department at 1-800-727-7846.
• Quantity in Commerce: 56 units
• Distribution: US Nationwide Distribution
• 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