BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1181372 · Received September 23, 2008

    Report

    Report Number
    1644487-2008-02296
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    July 26, 2001
    Report Date
    September 4, 2008
    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

    THE REPORTER INDICATED THAT IT WAS DURING THE ANALYSIS OF A VNS PATIENT'S GENERATOR, WHO UNDERWENT REVISION SURGERY DUE TO THE EXPECTED END OF SERVICE OF THE DEVICE, IT WAS REVEALED THAT A TRANSISTOR WITHIN THE DEVICE EXHIBITED AN OUT-OF-LIMIT (HIGHER) LEAKAGE CURRENT AT TEST CHAMBER TEMPERATURE. A BATTERY LONGEVITY PREDICTION PERFORMED BY THE MANUFACTURER, WHICH RESULTED IN -1.07 YEARS UNTIL ERI=YES, CONFIRMED THAT THE END OF SERVICE CONDITION WAS AN EXPECTED EVENT. THOUGH THE TRANSISTOR COULD HAVE CONTRIBUTED TO THE END OF THE SERVICE OF THE DEVICE, THIS SLIGHT LEAKAGE WOULD HAVE ONLY HAD A MINIMAL EFFECT ON THE EOS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 3673

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR