BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4232910 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21093
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE LEAD WAS INSERTED INTO THE HEADER, THE SETSCREW WOULD NOT CLICK OR SEAT ON THE LEAD. IT WAS ATTEMPTED FOUR OR FIVE TIMES, BUT COULD NOT BE TIGHTENED. THEY HAD NOT BACKED THE SETSCREW AT ALL. TRYING A DIFFERENT TORQUE WRENCH DID NOT RESOLVE THE ISSUE. THE LEAD WAS FULLY INSERTED AND SHOWED BLUE IN ALL OF THE WINDOWS. THE HEALTHCARE PROVIDER DID NOT FEEL THE SETSCREW TURN, BUT HAD ON A PREVIOUS ATTEMPT. THERE WAS TENSION ON THE LEAD. ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. FOLLOWING IMPLANT, THE PATIENT WAS DOING WELL AND WAS VERY PLEASED WITH THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713753 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1