BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1172596 · Received September 19, 2008

    Report

    Report Number
    1644487-2008-02275
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 21, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE IS SUSPECTED TO BE AT END OF SERVICE BECAUSE THE PATIENT IS EXPERIENCING AN INCREASE IN SEIZURES. BATTERY LIFE CALCULATIONS PERFORMED USING SETTINGS PROVIDED BY THE PHYSICIAN SHOW THAT THE PATIENT'S DEVICE IS NOT AT END OF SERVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT'S EVENT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR