BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1053116 · Received May 27, 2008

    Report

    Report Number
    1644487-2008-01231
    Event Type
    Death
    Date Received
    May 27, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS THERAPY PT DIED, YET THE CAUSE OF DEATH REMAINS UNK TO MFR AT THIS TIME. GOOD FAITH ATTEMPTS FOR FURTHER INFO, INCLUDING THE CAUSE AND DATE OF DEATH, ARE CURRENTLY BEING MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 7911

    Patients

    Seq Age Sex Outcome Treatment
    1 Death