BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 6169486 · Received December 13, 2016

    Report

    Report Number
    1644487-2016-02847
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    October 20, 2016
    Report Date
    December 1, 2016
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN SENT IN A PATIENT DEATH FORM STATING THAT A VNS PATIENT HAD PASSED AWAY DUE TO PROBABLE SUDEP. THE PATIENT REPORTEDLY EXPERIENCED SEIZURE REDUCTION WITH VNS AND WAS RECEIVING VNS STIMULATION AT THE TIME OF DEATH. NEITHER DEVICE WAS REPORTEDLY EXPLANTED AFTER THE PATIENT PASSED AWAY. THE DEATH WAS NOT ATTRIBUTED TO VNS AND NO AUTOPSY WAS PERFORMED AND THE PATIENT HAD A HISTORY OF NOCTURNAL SEIZURES AND WAS REPORTEDLY COMPLIANT WITH MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822272 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS - HOUSTON 103 3817

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death