BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 5533390 · Received March 29, 2016

    Report

    Report Number
    1644487-2016-00666
    Event Type
    Death
    Date Received
    March 29, 2016
    Report Date
    March 10, 2016
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(4) 2016 THAT THIS VNS PATIENT PASSED AWAY. THE PHYSICIAN FOUND OUT WHEN THEY TRIED TO CALL THE PATIENT TO CONFIRM AN APPOINTMENT. THE PATIENT PASSED AWAY IN (B)(6) 2016. HE WAS REPORTED AS BEING ILL AND DIED IN HIS SLEEP, BUT NO SPECIFICS ARE AVAILABLE. CLINIC NOTES FOR PATIENT (B)(6) RECEIVED ON (B)(4) 2016. THE NOTES WERE DATED (B)(6) 2012. NOTES STATE VNS HAS HELPED DECREASE HIS SEIZURES. SYSTEM DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THE INCOMING FAX FROM THE PHYSICIAN STATES THAT (B)(6) 2012 WAS THE LAST TIME THEY SAW THE PATIENT. THEREFORE, THERE IS NO COMMENTARY ON THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187759 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS - HOUSTON 104 2934

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death