BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2061881 · Received April 5, 2011

    Report

    Report Number
    3004209178-2011-02586
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST THERAPEUTIC EFFECT FOLLOWING A FALL. THE PATIENT FELL APPROXIMATELY "3 MONTHS AGO" FROM THE TIME OF REPORT. THE PATIENT WAS UNSURE IF HE FELT STIMULATION IMMEDIATELY AFTER THE FALL. THE PATIENT HAD GONE THROUGH ALL OF THE PROGRAMS AND HAD NO STIMULATION SENSATION. THE PATIENT WAS RE-DIRECTED TO HIS PHYSICIAN. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR LEAD: MODEL 3889, LOT# V535749| PROGRAMMER: MODEL 3037, LOT# NJD118335N| IMPLANTED:| EXPLANTED: