BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2061813 · Received March 30, 2011

    Report

    Report Number
    3004209178-2011-02416
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION. SPECIFICALLY, THE SHOCKING WAS DESCRIBED AS A "JOLTING THROBBING" SENSATION THAT RADIATED ACROSS HER BODY AND DOWN HER LEGS WHEN SHE WAS LYING DOWN. SHE SUBSEQUENTLY TURNED THE NEUROSTIMULATOR OFF AND FELT NOTHING AFTERWARDS. THE PT THEN TURNED THE DEVICE BACK ON AGAIN AND INCREASED THE STIMULATION WHICH WAS FELT AS NORMAL TO HER. ADDITIONAL INFO 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 56 YR PROGRAMMER: MODEL 3037, LOT # NJD101780N| IMPLANTED:| LEAD: MODEL 3889, LOT # UNK| EXPLANTED: