BEUDAMED
    FDA Recall Terminated

    Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control.

    Recall: Z-0037-2008 · Initiated June 25, 2007

    Recall

    Recall Number
    Z-0037-2008
    Event Number
    38371
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    EZW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 25, 2007
    Posted
    October 11, 2007
    Terminated
    October 8, 2010
    Address
    800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250

    Description

    Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control.

    Reason

    A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .

    Action

    Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient mangement of the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.

    Distribution

    Nationwide and the Netherlands.

    Quantity

    1885