BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1220477 · Received November 4, 2008

    Report

    Report Number
    1644487-2008-02663
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 6, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THE PATIENT NORMALLY HAS 1 SEIZURE A DAY (6/9 OFFICE VISIT) AND CURRENTLY EXPERIENCED 3 SEIZURES IN AN HOUR (10/2) OFFICE VISIT INDICATING THAT THE PATIENT IS EXPERIENCING AN INCREASE IN SEIZURES. THE PATIENT IS ALSO EXPERIENCING AN ALTERED PERCEPTION OF STIMULATION (NOT FEELING THE STIMULATION AT THE SAME MAGNITUDE AS BEFORE). FURTHER, DIAGNOSTICS CONFIRMED PROPER DEVICE FUNCTION THAT THE ERI FLAG IS NOT INDICATING THAT THE DEVICE HAS REACHED END OF BATTERY LIFE. THE PATIENT WAS SCHEDULED FOR VNS BATTERY REPLACEMENT. IT IS UNKNOWN IF THE PATIENT'S REPORTED SEIZURES WERE ABOVE THEIR PRE VNS SEIZURE RATE. GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL INFORMATION ABOUT THE EVENTS AND ATTEMPTS ARE BEING MADE FOR THE EXPLANTED PRODUCT FOR ANALYSIS.

    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 Other