BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1191843 · Received October 1, 2008

    Report

    Report Number
    3004209178-2008-06262
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IN AN AUTO ACCIDENT AND LOST THERAPY. THE DEVICE IMPEDANCES WERE TESTED; THE RESULTS ARE UNK. THE PT OUTCOME IS UNK. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037