BEUDAMED
    FDA Recall Terminated

    Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

    Recall: Z-1599-2010 · Initiated April 23, 2010

    Recall

    Recall Number
    Z-1599-2010
    Event Number
    55503
    Firm
    Advanced Neuromodulation Systems, Inc
    FEI Number
    1627487
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Manufacturing material removal
    Initiated
    April 23, 2010
    Posted
    May 13, 2010
    Terminated
    July 27, 2015
    Address
    6901 Preston Rd, Plano, TX, 75024-2508

    Description

    Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

    Reason

    Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.

    Action

    St. Jude Medical issued an "Important Medical Device Information" notification dated April 2010. Consignees were informed of the affected product and instructed on necessary steps. Any returned product should be sent to the firm. For further information, contact your St. Jude Medical Neuromodulation Division Sales Representative or call 1-972-309-2154.

    Distribution

    Nationwide Distribution -- GA, NC, CA, OK, SC and NJ.

    Quantity

    7 devices