BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 6139626 · Received December 1, 2016

    Report

    Report Number
    1644487-2016-02763
    Event Type
    Death
    Date Received
    December 1, 2016
    Date of Event
    September 20, 2014
    Report Date
    November 8, 2016
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A REPRESENTATIVE FROM THE PHYSICIAN'S OFFICE THAT THE PATIENT PASSED AWAY ON (B)(6) 2014. FROM THE DEATH CERTIFICATE AND PHYSICIAN'S OFFICE, IT WAS GATHERED THAT THE PATIENT WAS HAVING BREATHING PROBLEMS THE MORNING OF (B)(6) 2014. AN AMBULANCE WAS CALLED AND THE PATIENT DIED NATURALLY OF CARDIAC ARREST IN THE AMBULANCE. THE FUNERAL HOME STATED THE DEVICE WAS EXPLANTED AND DISCARDED. THE PHYSICIAN WAS NOT ABLE TO MAKE ANY ASSESSMENTS CONCERNING THE RELATIONSHIP BETWEEN VNS AND THE DEATH. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790250 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS - HOUSTON 103 2846

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death