BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN

    MDR report key: 1020366 · Received March 25, 2008

    Report

    Report Number
    1644487-2008-00779
    Event Type
    Death
    Date Received
    March 25, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 5, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED HE WAS RETURNING AN EXPLANTED VNS GENERATOR FROM A DECEASED PT. NO INFO ABOUT THE PT OR GENERATOR WAS PROVIDED BY THE REPORTER. ALL ATTEMPTS FOR ADD'L INFO AND GENERATOR RETURN FROM THE REPORTER HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN NONE LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death