BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1212583 · Received October 24, 2008

    Report

    Report Number
    1644487-2008-02558
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 26, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT BEGAN EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY. THE INCREASE IN SEIZURE ACTIVITY HAS BEEN ALLEGED TO BE DUE TO THE PATIENT'S GENERATOR REACHING END OF SERVICE. BATTERY LIFE CALCULATION PERFORMED ON THE GENERATOR SHOWED 5.44 YEARS UNTIL EOS = YES. NO MEDICATION CHANGES HAVE BEEN MADE. NO MALFUNCTION IS SUSPECTED WITH THE DEVICE BY THE PHYSICIAN. SURGERY IS PLANNED BUT HAS NOT BEEN SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 3274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention