BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1190658 · Received October 6, 2008

    Report

    Report Number
    3004209178-2008-06355
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Report Date
    September 8, 2008
    Manufacturer
    MPROC, JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST THEIR STIMULATION. A DISPLAY SHOWED "CALL YOUR DOCTOR" ICON WHICH WAS A POWER ON RESET CONDITION. FURTHER FOLLOW-UP WAS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MPROC, JUNCOS IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER: MODEL 3037