BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2023009 · Received February 24, 2011

    Report

    Report Number
    1644487-2011-00346
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 18, 2001
    Report Date
    February 17, 2011
    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

    DURING PRODUCT ANALYSIS FOR A VNS GENERATOR EXPLANTED DUE TO REPORTED END OF SERVICE, IT WAS NOTED THAT THE PULSING SUPPLY CURRENT WAS OUT OF SPEC AND WAS CAUSED BY A LEAKY Q10 COMPONENT. AFTER Q10 WAS REPLACED WITH KNOWN GOOD BENCH COMPONENT, THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECS. THE LEAKY Q10 COMPONENT COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END OF SERVICE; HOWEVER, PRODUCT ANALYSIS OF THE DEVICE DETERMINED THAT THE END OF SERVICE CONDITION WAS AN EXPECTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 1934

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR