BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5433734 · Received February 12, 2016

    Report

    Report Number
    3004209178-2016-02731
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Report Date
    January 23, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THEY NEEDED ASSISTANCE IN DECREASING STIMULATION. THE PATIENT STATED HIS SCROTUM WAS GETTING SHOCKED BY IMPLANT AND NEEDED TO DECREASE STIM. THE PATIENT HAD ATTEMPTED TO SYNC IMPLANT CONTROLLER AND RECEIVED SYMBOLS ON THE SCREEN. THE PATIENT STATED ON ONE SIDE OF SCREEN "IT LOOKED LIKE A LIL BATTERY WITH LINES COMING OUT OF IT AND ON THE OTHER SIDE THERE IS A LIL TABLE, WHERE A LEG WOULD BE THERE IS HALF AN L COLORED IN�TROUBLESHOOTING WAS ATTEMPTED WITH NO SUCCESS. THE PATIENT WAS PROVIDED WITH THE PATIENT SERVICES NUMBER. INDICATIONS FOR USE WAS NOTED AS: GASTROINTESTINAL/PELVIC FLOOR . NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92089 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR