BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1213804 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-06791
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION IN THE LABIA AREA AND IT WAS SENSITIVE TO THE TOUCH. THIS STARTED TEN DAYS AGO. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE LEAD IMPEDANCE MEASUREMENTS FOR ALL COMBINATIONS WITH ELECTRODE #3 READ GREATER THAN 4,000 OHMS. THE OTHER PAIRS WERE WITHIN NORMAL RANGE. THE PATIENT WAS IN THE CLINIC AND REPROGRAMMING THE DEVICE WAS SUCCESSFUL. VAGINAL STIMULATION WAS RECAPTURED. THE BURNING SENSATION WILL BE MONITORED. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    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 43 YR Required Intervention PROGRAMMER: MODEL 3037| LEAD: MODEL 3093| EXPLANTED:| IMPLANTED: