BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1061795 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03200
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 13, 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 COULD NOT ADJUST THE STIMULATION OF HER INTERSTIM DEVICE WITH HER PATIENT PROGRAMMER. THE IPG WILL NEED TO BE EXPLANTED TO DETERMINE IF IT IS THE SOURCE OF THE PROBLEM. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MPROC, JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3031A| LEAD: MODEL 3093| IMPLANTED:| EXTENSION: MODEL 3095| IMPLANTED: