BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 468765 · Received July 1, 2003

    Report

    Report Number
    1644487-2003-00371
    Event Type
    Death
    Date Received
    July 1, 2003
    Date of Event
    May 25, 2003
    Report Date
    June 3, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A VNS PATIENT HAD PASSED AWAY. IT WAS REPORTED THAT THE DEATH WAS PRESUMABLY DUE TO A SEIZURE IN THEIR SLEEP. EXACT CAUSE OF DEATH IS UNKNOWN AT THIS TIME. THERE IS NO EVIDENCE AT THIS TIME THAT NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT HAD REPORTEDLY EXPERIENCED A >50% REDUCTION IN SEIZURES WITH THE VNS THERAPY AND WAS RECEIVING VNS THERAPY AT THE TIME OF DEATH. TREATING NEUROLOGIST INDICATED THAT THE RELATIONSHIP BETWEEN THE EVENT AND THE NCP SYSTEM WAS UNKNOWN. AN AUTOPSY WAS PERFORMED. THE NCP SYSTEM WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 2525

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Death MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE:| OF DEATH: TOPIRAMATE, LAMOTRIGINE (DOSAGES UNK).| 11/30/2002, DATE OF MFG: 11/18/2000, STERILIZATION| LOT NO. 1452. ANTI-EPILEPTIC MEDICATIONS AT TIME