BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1012528 · Received March 11, 2008

    Report

    Report Number
    1644487-2008-00665
    Event Type
    Death
    Date Received
    March 11, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 12, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE VNS PATIENT PASSED AWAY. THE SITE REPORTED THAT THE PATIENT HAD ASPIRATED AND WAS TAKEN TO THE EMERGENCY ROOM WITH DECREASED OXYGEN. THE PATIENT CODED IN THE EMERGENCY ROOM AND WAS SUBSEQUENTLY PLACED ON A VENTILATOR. THE PATIENT REPORTEDLY EXPIRED DUE TO ASPIRATION AND RESPIRATORY DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 285

    Patients

    Seq Age Sex Outcome Treatment
    1 Death