BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1872360 · Received October 11, 2010

    Report

    Report Number
    3004209178-2010-07782
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    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 INTRAOPERATIVELY WITH A NEW DEVICE AND PT PROGRAMMER THERE WAS A 23 WARNING MESSAGE: UNCONFIRMED VALUES. THE COMPANY REP WAS ABLE TO INTERROGATE THE DEVICE AND SYNC WITH THE PT PROGRAMMER BUT AFTER SYNCHING, SHE GOT WARNING SCREEN AND WHEN SHE PRESSED P TO PROGRAM, SHE GOT TELEMETRY IN PROGRESS SCREEN, THEN IT SWITCHED BACK TO UNCONFIRMED VALUES WARNING MESSAGE. THE COMPANY REP COULD NOT GET OUT OF THIS WARNING SCREEN. IT ALTERNATED BETWEEN THIS WARNING SCREEN AND THE TELEMETRY IN PROGRESS SCREEN. PT REC'D A NEW INS AND WAS DOING FINE.

    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 41 YR IMPLANTED:| LEAD: MODEL 3889, LOT# V525448| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD113704N