BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3884101 · Received June 19, 2014

    Report

    Report Number
    1644487-2014-01538
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    September 17, 2011
    Report Date
    May 21, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S TREATING NEUROLOGIST REPORTED THAT THEY DO NOT HAVE A CAUSE OF DEATH OR ANY ADDITIONAL RELEVANT INFORMATION BECAUSE THEY WERE NOT THE PATIENT'S PRIMARY CARE GIVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. THE RELATIONSHIP OF THE DEATH TO VNS IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    A COPY OF THE DEATH CERTIFICATE WAS RECEIVED AND IT STATED THAT THE PATIENT WAS PRONOUNCED DEAD ON 09/17/2011. THE PATIENT WAS CREMATED AFTER DEATH. THE IMMEDIATE CAUSE OF DEATH WAS LISTED AS SEIZURE DISORDER DUE TO A CONSEQUENCE OF HYDROCEPHALIS. THE MANNER OF DEATH WAS NATURAL AND NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360564 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death