BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2851654 · Received November 29, 2012

    Report

    Report Number
    3007566237-2012-02874
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    PRODUCT ID: 3037, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A POR (POWER ON RESET) CONDITION. THE REPORTER STATED THAT THE PATIENT WAS DOING WELL. IT WAS REPORTED THAT THE CLINIC THOUGHT THAT THE PATIENT WAS AT A COURTHOUSE AND POSSIBLY GOING THROUGH DETECTORS MAY HAVE CAUSED THE ISSUE. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1