BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4090720 · Received September 15, 2014

    Report

    Report Number
    1644487-2014-02350
    Event Type
    Death
    Date Received
    September 15, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WILL BE MADE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT¿S DEATH WAS NOT BELIEVED TO BE RELATED TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570315 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 010275

    Patients

    Seq Age Sex Outcome Treatment
    1 Death