BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1232716 · Received November 14, 2008

    Report

    Report Number
    1644487-2008-02750
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: X-RAYS REVIEWED BY THE MANUFACTURER, AND NO GROSS LEAD DISCONTINUITIES WERE VISUALIZED, ALTHOUGH IT IS POSSIBLE THE ELECTRODE IS OFF OF THE NERVE. CONCLUSIONS: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT HAD HIGH IMPEDANCE ON BOTH SYSTEM AND NORMAL MODE DIAGNOSTICS. THERE HAS BEEN NO TRAUMA OR MANIPULATION OF THE DEVICE AND NO PATIENT ADVERSE EVENTS. A BATTERY LIFE CALCULATION WAS DONE AND REVEALED APPROXIMATELY 2.59 YEARS REMAINING UNTIL END OF SERVICE. X-RAYS WERE REVIEWED BY THE MANUFACTURER, AND NO DEVICE ANOMALIES WERE FOUND, ALTHOUGH IT IS IMPORTANT TO NOTE THAT IT IS POSSIBLE THE NEGATIVE ELECTRODE WAS OFF THE NERVE AS THE ELECTRODES WERE NOT ALIGNED VERTICALLY AS WOULD BE EXPECTED. PRODUCT HAS BEEN REQUESTED, BUT HAS NOT BEEN RETURNED TO MANUFACTURER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 010657

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR