BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1542723 · Received November 17, 2009

    Report

    Report Number
    1644487-2009-02572
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Date of Event
    May 7, 2002
    Report Date
    November 11, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A VNS PT HAD GENERATOR REPLACEMENT SURGERY DUE TO END OF SERVICE. THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS AND IT WAS IDENTIFIED THAT TRANSISTOR Q10 WAS FOUND TO EXHIBIT AN OUT-OF-LIMIT (HIGHER) LEAKAGE CURRENT AT TEST CHAMBER TEMPERATURE. THIS LEAKAGE INCREASED THE MODULE'S SUPPLY CURRENT 1MA CONSUMPTION BY APPROX 1.194UA OVER THE HIGH LIMIT (SPEC 23.000-38.000MA). THE OUT-OF-LIMIT PULSING CURRENTS COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END OF SERVICE, HOWEVER, THE BATTERY LONGEVITY CALCULATION (-0.33 YEARS) DETERMINED THAT THE END OF SERVICE WAS AN EXPECTED EVENT. AS THE GENERATOR WAS RECEIVED IN AN END OF SERVICE STATE, THE EXTENT TO WHICH THE INCREASED CURRENT CONSUMPTION MAY HAVE CONTRIBUTED TO A DEPLETED BATTERY CANNOT BE DETERMINED. THE CAGED MODULE MET SPEC FOLLOWING THE Q10 REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 5985

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR