BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 6070509 · Received November 1, 2016

    Report

    Report Number
    1644487-2016-02536
    Event Type
    Death
    Date Received
    November 1, 2016
    Date of Event
    May 23, 2015
    Report Date
    January 30, 2017
    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
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP TO THE CARE FACILITY WHERE THE PATIENT LIVED PROVIDED THAT THE CAUSE OF DEATH WAS PNEUMONIA, AND PROVIDED IT WAS NOT RELATED TO VNS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CASE MANAGER AFTER ROUTINE FOLLOW-UP FOR END-OF-SERVICE THAT A PATIENT WAS DECEASED. AN ONLINE OBITUARY PROVIDED THAT THE PATIENT DIED SUDDENLY ON (B)(6) 2015. ADDITIONAL RELEVANT INFORMATION HAS NOT BEEN RECEIVED TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720319 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3184

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death