BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4051841 · Received September 2, 2014

    Report

    Report Number
    1644487-2014-02150
    Event Type
    Death
    Date Received
    September 2, 2014
    Date of Event
    February 11, 2009
    Report Date
    August 4, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2009. THE CAUSE OF DEATH AND THE RELATIONSHIP OF THE DEATH TO VNS ARE UNKNOWN. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE CAUSE OF DEATH IS NOTED TO BE SEPTICEMIA. THE PATIENT'S LAST KNOWN TREATING PHYSICIAN PASSED AWAY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534486 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 010789

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death