BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 511979 · Received February 18, 2004

    Report

    Report Number
    1644487-2004-00137
    Event Type
    Death
    Date Received
    February 18, 2004
    Date of Event
    December 1, 2003
    Report Date
    January 19, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PT HAD PASSED AWAY. TREATING NEUROLOGIST INDICATED THAT THE PT DIED FROM PNEUMONIA AND THAT THE PT HAD A HEMORRHAGE OF THE BRAIN. NO AUTOPSY WAS PERFORMED. THE PT REPORTEDLY EXPERIENCED >50% REDUCTION IN SEIZURES WITH THE VNS THERAPY AND WAS RECEIVING THERAPY AT THE TIME OF DEATH. TREATING NEUROLOGIST INDICATED THAT THE PT'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. 100 18102C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death 4. KEPPRA.| EXPIR 07/31/2000, DATE OF MFG 07/21/1998,| 3. VALPROATE/VALPROIC ACID,| 2. CARBAMAZEPINE,| 1. MODEL 300-30 NCP BIPOLAR LEAD,| MEDICATIONS AT TIME OF DEATH INCLUDE:| STERILIZATION LOT NO. 13667C.