BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1950382 · Received December 14, 2010

    Report

    Report Number
    3004209178-2010-10437
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 8, 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
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A SUDDEN LOSS OF STIMULATION WITH A SUBSEQUENT FULL RETURN OF SYMPTOMS. THERE WAS NO KNOWN RELATED ACCIDENT OR INCIDENT. THE PT WAS SEEN IN CLINIC AND WHEN TESTED, ALL UNIPOLAR PAIR IMPEDANCES WERE GREATER THAN 4,000 OHMS. THE TESTS WERE RE-RUN AFTER INCREASING VOLTAGE AND PULSE WIDTH AND THE RESULTS WERE THE SAME. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    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 71 YR LEAD: MODEL 3889, LOT# V302593| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD087568N