BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1061802 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03234
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN INTERSTIM DEVICE WAS UNABLE TO ADJUST HER STIMULATION. UPON TESTING HER STIMULATION, BOTH HIGH AND LOW IMPEDANCES WERE FOUND. THE PATIENT TURNED HER DEVICE UP ALL THE WAY TO 10 VOLTS AND STILL DID NOT FEEL ANY STIMULATION. TECHNICAL SERVICES PROVIDED RECOMMENDATIONS FOR REPROGRAMMING THE DEVICE. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR IMPLANTED:| EXPLANTED:| LEAD MODEL 3889| PROGRAMMER MODEL 3037| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 3095| EXPLANTED:| IMPLANTED: