BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3955801 · Received July 24, 2014

    Report

    Report Number
    1644487-2014-01863
    Event Type
    Death
    Date Received
    July 24, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 26, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. IT WAS REPORTED THAT THE OFFICIAL CAUSE OF DEATH IS UNKNOWN, BUT THAT THE PATIENT SUFFERED FROM MULTIPLE ISSUES. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT IT WAS FELT THAT VNS HELPED THE PATIENT LIVE AS LONG AS POSSIBLE. IT WAS REPORTED THAT THE PATIENT RESPONDED TO VNS THERAPY AND IT SEEMED TO GIVE THE PATIENT BACK CONTROL OF HIS LIFE. IT WAS REPORTED THAT THE PATIENT WAS IN HOSPICE CARE AT THE TIME OF HIS DEATH. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434153 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202100

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention