BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1180993 · Received September 29, 2008

    Report

    Report Number
    3004209178-2008-06190
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MPROC, JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1