BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2061899 · Received April 5, 2011

    Report

    Report Number
    3004209178-2011-02583
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    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
    MN, 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 AN "ODD STIMULATION AND SHOCKING" AT THE NEUROSTIMULATOR SITE. IT WAS ALSO NOTED THAT THE DEVICE WAS "GETTING CLOSE TO END OF LIFE" SHOW THE PHYSICIAN DECIDED TO IMPLANT A NEW NEUROSTIMULATOR ON THE PATIENT'S RIGHT SIDE. THE OLD DEVICE SYSTEM ON THE LEFT SIDE REMAINED IMPLANTED IN THE PATIENT. SEE MANUFACTURER REPORT # 3004209178201007721 FOR NEW NEUROSTIMULATOR EVENT.

    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 47 YR EXPLANTED:| LEAD: MODEL 3889, LOT# V216390| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD082882N