BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1980298 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-00814
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 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
    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 HAD HER DEVICE MOVED. WHEN THE PATIENT CAME OUT OF SURGERY, THE PATIENT'S MOTHER DECIDED TO TURN THE DEVICE ON. THE PATIENT WAS IN A GREAT DEAL OF PAIN AND COULD NOT FIGURE OUT HOW TO TURN THE DEVICE OFF. THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND THE DISPLAY SHOWED "CALL YOUR DOCTOR." THE DEVICE WAS IN A POWER ON RESET (POR) CONDITION AS WELL. WHEN THE PATIENT ATTEMPTED TO SYNCH THE PROGRAMMER WITH THE DEVICE, THE PAIN INCREASED. IT WAS NOTED THAT A "BEAR PAW" WARMING DEVICE WAS USED AND MAY HAVE CAUSED INTERFERENCE. A COMPANY REP MET WITH THE PT IN THE HOSPITAL. THE REP TURNED ALL SETTINGS TO 0 AND REPROGRAMMED/MADE ADJUSTMENTS. THE PATIENT MET WITH HER PHYSICIAN AND THE COMPANY REP ON (B)(6) 2011 AND WAS DOING "GREAT AND IN GREAT SPIRITS". THERE APPEARED TO BE NO FURTHER ISSUES.

    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 25 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD116303N| LEAD: MODEL 3889, LOT# V567717