BEUDAMED
    FDA Recall Terminated

    Eon Mini Neurostimulation (IPG) System Model 3788 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-2607-2011 · Initiated May 24, 2011

    Recall

    Recall Number
    Z-2607-2011
    Event Number
    56787
    Firm
    Advanced Neuromodulation Systems Inc.
    FEI Number
    1627487
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 24, 2011
    Posted
    June 22, 2011
    Terminated
    July 21, 2015
    Address
    6901 Preston Rd, Plano, TX, 75024-2508

    Description

    Eon Mini Neurostimulation (IPG) System Model 3788 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

    Defective battery was identified as cause for reports of inability to communicate or recharge the product.

    Action

    St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers. St. Jude Medical recommends no action be taken if the product serial numbers do not match the numbers listed in the letter. For product remaining in unimplanted inventory, customers are instructed to contact their SJM representative so that product may be returned and replacements be provided. For implanted product that matches the serial numbers, the Medical Advisory Board recommend not to unnecessarily explant the devices if they are functioning as intended. Replacement devices will be provided at no additional cost to the customer. A Product Reconciliation Form was attached to the letter for customers to complete and return any unused product to the St. Jude Medical Neuromodulation Division at 6901 Preston Road., Plano, TX 75024. Questions regarding this recall are directed to the customer's St. Jude Medical Neuromodulation Division Representative.

    Distribution

    Worldwide Distribution-- USA (nationwide) including PUERTO RICO and countries of AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, FINLAND,FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, and UNITED KINGDOM.

    Quantity

    17,141