BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1081952 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-04262
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS PUSHING A STROLLER WHILE WALKING IN A MALL; SHE WALKED OVER A METAL GRATE IN THE FLOOR AND WAS SHOCKED IN HER ARM AND HAND. SHE TOOK SEVERAL MORE STEPS AND WAS SHOCKED THREE MORE TIMES. THE PATIENT WAS ABLE TO TURN OFF HER IPG AND HAS NOT TURNED IT BACK ON. THE PATIENT WAS REPORTED TO BE AT HOME IN FAIR CONDITION. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR EXTENSION: MODEL 3095| PROGRAMMER: MODEL 3031A| LEAD: MODEL 3886| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: