BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 4641033 · Received March 30, 2015

    Report

    Report Number
    1644487-2015-04287
    Event Type
    Death
    Date Received
    March 30, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 4, 2015
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN BY THE PHYSICIAN'S ASSISTANT. THE FUNERAL HOME DIRECTOR INDICATED THAT THE PATIENT WAS BURIED WITH THE DEVICE AND THAT THE IMMEDIATE CAUSE OF DEATH WAS HEART FAILURE DUE TO ATRIAL FIBRILLATION >3 YEARS, DUE TO OR AS A CONSEQUENCE OF ATRIAL FIBRILLATION >3 YEARS, DUE TO OR AS A CONSEQUENCE OF SLEEP APNEA >5 YEARS. THE DEATH CERTIFICATE NOTED OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH, BUT NOT RESULTING IN THE UNDERLYING CAUSE WAS SERIOUS ANEMIA. NO AUTOPSY WAS PERFORMED. THE MANNER OF DEATH WAS LISTED AS NATURAL, AND TOBACCO DID NOT CONTRIBUTE TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209421 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R 201883

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death