BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 524854 · Received May 13, 2004

    Report

    Report Number
    1644487-2004-00374
    Event Type
    Death
    Date Received
    May 13, 2004
    Date of Event
    April 11, 2004
    Report Date
    April 15, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VNS PATIENT PASSED AWAY DUE TO HEAD TRAUMA. IT WAS REPORTED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE NCP SYSTEM. THERE IS NO EVIDENCE AT THIS TIME THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 40548C

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death MODEL 300-20 NCP BIPOLAR LEAD,| EXPIR DATE 06/30/2002, DATE OF MFG 05/30/2000,| STERILIZATION LOT NO. 39500C.