BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0025-2013 · Reported October 17, 2012

    Enforcement

    Recall Number
    Z-0025-2013
    Event ID
    63154
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Neuromodulation Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2012
    Initiation Date
    September 4, 2012
    Classification Date
    October 9, 2012
    Termination Date
    May 12, 2014
    Address
    6901 Preston Rd, N/A, Plano, TX, 75024-2508, United States

    Description

    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.

    Reason

    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.

    Code Info

    Eon Mini - 3788 (IPG), Multiple Serial Numbers

    Distribution

    US Nationwide Distribution

    Quantity

    56 units