BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1905731 · Received November 19, 2010

    Report

    Report Number
    1644487-2010-02635
    Event Type
    Death
    Date Received
    November 19, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD PASSED AWAY UNEXPECTEDLY AT HOME, DUE TO UNK REASONS. THE PT HAS HAD AN AUTOPSY PERFORMED, BUT THE REPORT IS NOT EXPECTED TO BE IMMEDIATELY AVAILABLE. THE PT'S VNS DEVICE WAS NOT EXPLANTED AND IS BURIED WITH THE PT. THE PT'S LAST KNOWN SETTINGS WITH HIS PEDIATRIC NEUROLOGIST WERE WITHIN NORMAL LIMITS. NO FURTHER INFO HAS BEEN IMMEDIATELY MADE AVAILABLE FROM HIS ADULT NEUROLOGIST. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS INC 103 201022

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death