BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 645807 · Received November 11, 2005

    Report

    Report Number
    1644487-2005-00767
    Event Type
    Death
    Date Received
    November 11, 2005
    Date of Event
    October 8, 2005
    Report Date
    October 13, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PATIENT HAD PASSED AWAY, PRESUMABLY DUE TO CARDIAC ARREST. THE PATIENT WAS FOUND UNRESPONSIVE ON THE KITCHEN FLOOR. AUTOPSY WAS NOT PERFORMED. THE PT REPORTEDLY BENEFITED FROM THE VNS THERAPY AND WAS RECEIVING THERAPY AT THE TIME OF DEATH. DEVICE DIAGNOSTIC TESTING PERFORMED APPROXIMATELY TWO MONTHS PRIOR TO DEATH WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION AT THAT TIME. THERE IS NO EVIDENCE AT THIS TIME THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    CERTIFICATE OF DEATH LISTS ASYSTOLE AS THE IMMEDIATE CAUSE OF DEATH, DUE TO OR AS A CONSEQUENCE OR RESPIRATORY ARREST (MINUTES) DUE TO OR AS A CONSEQUENCE OF CARDIAC ARREST (MINUTES), DUE TO OR AS A CONSEQUENCE OF SEIZURE DISORDER. THE PATIENT DIED IN THE HOSPITAL EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 3791

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death