BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 362940 · Received November 21, 2001

    Report

    Report Number
    1644487-2001-00619
    Event Type
    Death
    Date Received
    November 21, 2001
    Date of Event
    August 14, 2001
    Report Date
    October 22, 2001
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PATIENT DIED IN A FOREST WITHOUT WITNESS; PROBABLE CAUSE OF DEATH REPORTED AS STATUS EPILEPTICUS. IT WAS REPORTED THAT THE PATIENT HAS RECEIVED A 25% REDUCTION IN SEIZURES WITH THE NCP SYSTEM. PHYSICIAN INDICATED THAT THE NCP SYSTEM WAS NOT RELATED TO THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52808 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 100 20644C

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death MODEL 300-20 NCP BIPOLAR LEAD.