BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2050016 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-02450
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING EXPOSURE TO A THEFT DETECTOR OR SECURITY GATE AND THEN A WAND AT A COURTHOUSE. THE PATIENT WAS UNABLE TO INCREASE HER SETTINGS PAST A CERTAIN POINT AND THE SETTINGS FELT DIFFERENT. REGARDING THE PATIENT PROGRAMMER, THE PATIENT WAS UNABLE TO ADJUST STIMULATION; IT APPEARED THE UPPER LIMIT WAS REACHED. IT APPEARED THE PATIENT HAD TO DEVICE SYSTEMS - SEE MANUFACTURING REPORT # 3004209178201102452. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR PROGRAMMER: MODEL 3037, LOT# NJD116290N| IMPLANTED:| LEAD: MODEL 3889, LOT# V471354| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD108321N| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V574073| LOT# NJY159303H| IMPLANTABLE NEURO STIMULATOR: MODEL 3058,