BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1101983 · Received August 6, 2008

    Report

    Report Number
    1644487-2008-01800
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. THE RELATIONSHIP TO PREVNS BASELINE SEIZURE LEVELS IS UNKNOWN. USING THE PATIENT'S PROGRAMMING HISTORY, A BATTERY LIFE CALCULATION SHOWED 2.56 YEARS REMAINING UNTIL THE GENERATOR REACHES END OF SERVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other