BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 627007 · Received August 16, 2005

    Report

    Report Number
    1644487-2005-00534
    Event Type
    Death
    Date Received
    August 16, 2005
    Date of Event
    July 19, 2005
    Report Date
    July 19, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PT DIED WHILE HOSPATILIZED. DEATH CERTIFICATE LISTED THE IMMEDIATE CAUSE OF DEATH AS STATUS EPILEPTICUS, DUE TO (OR AS A CONSEQUENCE OF) AC RESPIRATORY FAILURE, DUE TO (OR AS A CONSEQUENCE OF) SEVERE MENTAL RETARDATION, DUE TO (OR AS A CONSEQUENCE OF) HYDROCEPHALUS. THE MANNER OF DEATH WAS LISTED AS NATURAL.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PT HAD PASSED AWAY. THE PT'S BODY IS BEING DONATED TO SCIENCE. CAUSE IS DEATH IS NOT KNOWN AT THIS TIME. NO AUTOPSY WAS PERFORMED. THE PT EXPERIENCED A >25% REDUCTION IN SEIZURES WITH THE VNS THERAPY AND WAS RECEIVING THERAPY AT THE TIME OF DEATH. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY AFFECT DEVICE PERFORMANCE. 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 40535C

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death