BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2150791 · Received June 21, 2011

    Report

    Report Number
    1644487-2011-01386
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    February 24, 2011
    Report Date
    May 23, 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

    AN EXPLANTED GENERATOR WAS RECEIVED FOR ANALYSIS REPLACED FOR END OF BATTERY LIFE. THE REPORTED END OF SERVICE AND LOW BATTERY WAS CONFIRMED IN THE PRODUCT ANALYSIS LAB. AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE DETERMINED THAT THE BATTERY WAS DEPLETED. THE POST BURN-IN ELECTRICAL TEST IDENTIFIED AN OUT-OF-SPECIFICATION CONDITION WITH SUPPLY CURRENT 1MA. BENCH ANALYSIS DETERMINED THAT THE OUT-OF-SPECIFICATION CONDITION WAS CAUSED BY A LEAKY Q10 COMPONENT. AFTER Q10 WAS SUBSTITUTED, THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO PROGRAMMING HISTORY RECORDS WERE FOUND; CONSEQUENTLY, A BATTERY LIFE CALCULATION COULD NOT BE PERFORMED. THE OUT-OF-SPECIFICATION SUPPLY CURRENT 1MA COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END OF SERVICE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 3897

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR