BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 6078521 · Received November 4, 2016

    Report

    Report Number
    1644487-2016-02552
    Event Type
    Death
    Date Received
    November 4, 2016
    Report Date
    October 11, 2016
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ARTICLE TITLE "SOCIOECONOMIC EVALUATION OF VAGUS STIMULATION:A CONTROLLED NATIONAL STUDY" WAS RECEIVED BY THE MANUFACTURER AND REVIEWED. THE DEATH OF A VNS PATIENT IS REPORTED. NO INFORMATION IS PROVIDED REGARDING THE CAUSE OF THE DEATH. PATIENT INFORMATION AND IMPLANT INFORMATION ARE NOT SPECIFIED. ATTEMPTS TO GET FURTHER INFORMATION WERE UNSUCCESSFUL. SUDEP EVALUATION PERFORMED BY THE MANUFACTURER CLASSIFIED THE DEATH AS POSSIBLE SUPEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729250 PULSE GEN MODEL UNKNOWN GENERATOR, MODEL UNKNOWN LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death