BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1213113 · Received October 23, 2008

    Report

    Report Number
    1644487-2008-02562
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    August 19, 2008
    Report Date
    October 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING THEIR VNS GENERATOR REPLACED FOR THE BATTERY "BEING LOW." THE GENERATOR WAS RETURNED FOR ANALYSIS. THE REPORTED END OF SERVICE (EOS) CONDITION WAS DUPLICATED IN THE LABORATORY. TESTING ON THE GENERATOR DEMONSTRATED AN INCREASED CURRENT CONSUMPTION FOR THE DEVICE, RESULTING IN A PREMATURE END OF LIFE CONDITION. THE PREMATURE END OF LIFE CONDITION WAS IDENTIFIED TO BE A LEAKY CAPACITOR, C6. WITH THE CAPACITOR SUBSTITUTION FOR C6, THE MODULE MEETS POST-BURN ELECTRICAL TEST SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 011296

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR