BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4728389 · Received April 24, 2015

    Report

    Report Number
    1644487-2015-04566
    Event Type
    Death
    Date Received
    April 24, 2015
    Date of Event
    July 28, 2012
    Report Date
    March 31, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEATH CERTIFICATE LISTED THE IMMEDIATE CAUSE OF DEATH AS SEPTIC SHOCK, DUE TO (OR AS A CONSEQUENCE OF) FEBRILE NEUTROPENIA, DUE TO (OR AS A CONSEQUENCE OF) DIFFUSE LARGE B-CELL LYMPHOMA. THE MANNER OF DEATH WAS LISTED AS NATURAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY IN 2012. THE PSYCHIATRIST DID NOT KNOW THE CAUSE OF DEATH. AN ONLINE OBITUARY WAS FOUND WHICH IDENTIFIED THE DATE OF DEATH AND THAT THE PATIENT PASSED AWAY IN THE HOSPITAL. THE FUNERAL HOME INDICATED THAT THE PATIENT WAS CREMATED AND THAT THE DEVICE WAS EXPLANTED AND DISCARDED; THEREFORE NO ANALYSIS CAN BE PERFORMED. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273611 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 014818

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death