BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1070005 · Received July 2, 2008

    Report

    Report Number
    1644487-2008-01505
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT DURING IMPLANT PROCEDURE, THE PHYSICIAN WAS UNABLE TO GET THE HEX SCREW DRIVER TO "CLICK". HE STATED THE LEAD APPEARED TO BE INSERTED, AND SEEMED TO BE "FULLY SEATED" WHEN THE PHYSICIAN TRIED TO PULL THE LEAD OUT. AS THE SCREW WAS TURNED, THEY FELT AND HEARD A SLIGHT CLICK. THEY COULD NOT GET THE WRENCH TO CLICK AGAIN. THEY WERE UNABLE TO BACK THE SCREW OUT OF THE GENERATOR. THEY PULLED ON THE CONNECTOR PIN BOOT, AND THE CONNECTOR PIN THAT WAS FULLY INSERTED INTO THE CONNECTOR BLOCK, DID NOT MOVE. THEY CLAMPED A NEEDLE HOLDER TO THE SHAFT OF THE HEX WRENCH TO SEE IF THEY COULD CHECK TO SEE IF THEY COULD GET THE WRENCH TO CLICK AND WERE UNABLE TO. IT WAS NOT CLEAR IF THE WRENCH APPEARED TO BE LOCKED OR WAS STRIPPED. SYSTEMS DIAGNOSTICS WERE PERFORMED AND WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 015709

    Patients

    Seq Age Sex Outcome Treatment
    1