BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 4151336 · Received October 8, 2014

    Report

    Report Number
    1644487-2014-02577
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE CAUSE OF DEATH AND ITS RELATIONSHIP TO VNS ARE UNKNOWN. THE PATIENT¿S DEVICE IS EXPECTED TO BE BURIED WITH THE PATIENT, SO NO ANALYSIS CAN BE PERFORMED. NO FURTHER INFORMATION RELEVANT TO THE EVENT HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632673 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death