BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1040372 · Received May 6, 2008

    Report

    Report Number
    1644487-2008-01089
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    January 15, 2008
    Report Date
    April 30, 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

    IT WAS REPORTED TO MANUFACTURER THAT THE VNS PT HAD THEIR GENERATOR REPLACED DUE TO END OF SERVICE. A BATTERY LIFE CALCULATION WAS PERFORMED AND WAS CALCULATED TO BE -2.60 YEARS UNTIL ERI (THE IMPLANT TIME EXCEED THE BATTERY LIFE ESTIMATE). THE GENERATOR WAS RETURNED TO MANUFACTURER FOR ANALYSIS. THE ANALYSIS FINDINGS SUPPORTED THE REPORTED END OF SERVICE CLAIM BASED ON BATTERY VOLTAGE MEASURING 1.878 VOLTS (DEPLETED). DURING TESTING, 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 APPROXIMATELY 5.137UA OVER THE HIGH LIMIT (SPEC 23.000 - 38.000MA) AND COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END OF SERVICE OF THE GENERATOR. HOWEVER, RESULTS OF THE BATTERY LONGEVITY PREDICTION CONFIRM THAT THE END OF SERVICE CONDITION WAS AN EXPECTED EVENT. WHEN THE Q10 COMPONENT WAS REPLACED, THE DEVICE WAS TESTED AGAIN, AND SUBSEQUENTLY MET MANUFACTURERS TEST SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 1726

    Patients

    Seq Age Sex Outcome Treatment
    1