BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2244001 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-06754
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT ADJUST STIMULATION, WITH OR WITHOUT THE ANTENNA ATTACHED. IMPEDANCE READINGS WERE LATER MEASURED AT OVER 4,000 OHMS ON MOST OF THE BIPOLAR PAIRS. THE ONLY VIABLE PAIRS WERE C AND 0, C AND 3, AND 0 AND 3. THE PATIENT MAY HAVE HAD A FALL, BUT DID NOT REMEMBER THE DETAILS OF THE FALL. THE DEVICE WAS REPROGRAMMED TO ADDRESS STIMULATION NEEDS, BUT WHEN THE VOLTAGE WAS ADJUSTED TO GET IT EFFECTIVE THE PATIENT DID NOT HAVE FULL LEG MOVEMENT. X-RAYS APPEARED TO SHOW THE LEAD IN THE CORRECT LOCATION, BUT WERE NOT CONCLUSIVE. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION. THE PATIENT'S IMPLANT WAS TURNED OFF AND A LEAD REVISION WAS PLANNED WITH A DATE TO BE DETERMINED. THE PATIENT'S SYMPTOMS WORSENED AFTER TURNING OFF THE DEVICE, AND THE PATIENT WAS GIVEN PERMISSION TO TURN IT BACK ON IF SHE FELT SHE COULD GET SOME RELIEF. THE IMPEDANCE VALUES WERE STILL HIGH ON 7 OF THE 10 PAIRS.

    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 49 YR IMPLANTED:| LEAD: MODEL 3889, LOT# V581952| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD118285N