BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1062995 · Received June 18, 2008

    Report

    Report Number
    1644487-2008-01417
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    February 29, 2008
    Report Date
    June 13, 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

    INITIAL REPORTER INDICATED THE PATIENT'S VNS WAS REPLACED FOR BEING AT END OF BATTERY LIFE. EOS WAS CONFIRMED BASED ON BATTERY VOLTAGE MEASURING 1.495 VOLTS (DEPLETED). THE REMAINING BATTERY LONGEVITY WAS CALCULATED TO BE - 2.01 YEARS UNTIL ERI. THE VALUES USED TO PERFORM THE BATTERY LIFE ESTIMATE MAY NOT BE REPRESENTATIVE OF THE ENTIRE PERIOD OF CUSTOMER/PATIENT USE. THE GENERATOR WAS IMPLANTED FOR 5.10 YEARS ((B) (6) 2003 - (B) (6) 2008). DURING TESTING, TRANSISTORS Q9 AND Q10 (COMBINED) WERE FOUND TO EXHIBIT OUT-OF-LIMIT (HIGHER) LEAKAGE CURRENTS AT TEST CHAMBER TEMPERATURE. THIS LEAKAGE INCREASED THE MODULE'S SUPPLY CURRENT 1MA CONSUMPTION BY APPROXIMATELY 7.876UA OVER THE HIGH LIMIT (SPEC 23.000 - 38.000 MA) AND COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END OF BATTERY LIFE. HOWEVER, RESULTS OF THE BATTERY LONGEVITY PREDICTION CONFIRM THAT THE EOS CONDITION WAS AN EXPECTED EVENT. THE CAGED MODULE MET ALL SPECIFICATIONS AS DEFINED BY CYBERONICS POST BURN-IN ELECTRICAL TEST SPECIFICATION AFTER THAT Q9/Q10 REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 7310

    Patients

    Seq Age Sex Outcome Treatment
    1