BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1230460 · Received November 7, 2008

    Report

    Report Number
    1644487-2008-02695
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 8, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT WAS HAVING DEVICE REPLACED DUE TO END OF SERVICE. NO ADVERSE EVENTS WERE REPORTED. PRODUCT WAS RETURNED TO MANUFACTURER AND UNDERWENT ANALYSIS. UPON ANALYSIS, IT WAS FOUND THAT END OF SERVICE AS A RESULT OF BATTERY DEPLETION WAS CONFIRMED. A BATTERY LIFE CALCULATION SHOWED -0.03 YEARS REMAINING UNTIL END OF SERVICE. DURING TESTING, TRANSISTOR Q9 WAS FOUND TO EXHIBIT AN OUT-OF-LIMIT LEAKAGE CURRENT AT TEST CHAMBER TEMPERATURE. THIS LEAKAGE COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END OF SERVICE. HOWEVER, RESULTS OF THE BATTERY LONGEVITY PREDICTION CONFIRM THAT THE END OF SERVICE CONDITION WAS AN EXPECTED EVENT AND THIS SLIGHT LEAKAGE IS EXPECTED TO HAVE ONLY A MINIMAL EFFECT ON THE END OF SERVICE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 1090

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR