BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 529731 · Received June 14, 2004

    Report

    Report Number
    1644487-2004-00472
    Event Type
    Death
    Date Received
    June 14, 2004
    Date of Event
    April 28, 2004
    Report Date
    May 20, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PT HAD PASSED AWAY FROM A STOMACH HEMORRHAGE. THE PT WAS REPORTEDLY RIDING IN THE CAR AND BEGAN TO VOMIT BLOOD. THE PT'S FAMILY MEMBER PERFORMED CPR UNTIL EMERGENCY MEDICAL CREW ARRIVED, BUT THE PT DIED WHILE EN ROUTE TO HOSPITAL. NO AUTOPSY WAS PERFORMED. THE DEATH CERTIFICATE LISTED THE IMMEDIATE CAUSE OF DEATH AS CARDIOPULMONARY ARREST, DUE TO (OR AS A CONSEQUENCE OF) "ASHYSIM", DUE TO (OR AS A CONSEQUENCE) ASPIRATION OF EMESIS, DUE TO (OR AS A CONSEQUENCE OF) CEREBRAL PALSY. THE MANNER OF DEATH WAS LISTED AS NATURAL. 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 3151

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death NCP BIPOLAR LEAD, MODEL & S/N UNKNOWN.