BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2844921 · Received November 26, 2012

    Report

    Report Number
    1644487-2012-03094
    Event Type
    Death
    Date Received
    November 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER PERFORMED A SUDEP EVALUATION AND BASED ON THE INFORMATION AVAILABLE, THE DEATH WAS DETERMINED TO BE POSSIBLE SUDEP.

    Description of Event or Problem · 1

    CAUSE OF DEATH INFORMATION OBTAINED FROM THE NATIONAL DEATH INDEX (NDI) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2012 AND THE PATIENT'S CAUSE OF DEATH WAS DUE TO MULTIPLE MYELOMA. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    Description of Event or Problem · 1

    ON (B)(6) 2012 A VNS TREATING NEUROLOGIST REPORTED THAT THE VNS PATIENT HAD PASSED AWAY. NO ADDITIONAL INFORMATION ABOUT THE CAUSE OF DEATH OR DATE OF DEATH WAS PROVIDED AT THAT TIME. THE PATIENT'S OBITUARY WAS FOUND ONLINE WHICH REPORTED THAT THE DATE OF DEATH WAS (B)(6) 2012. THE OBITUARY FURTHER STATED THAT THE PATIENT DIED THAT MORNING AT A HOSPICE AFTER AN EXTENDED ILLNESS. THE PATIENT'S NEUROLOGIST REPORTED THAT THE PATIENT WAS SEEN BY THEM ON (B)(6) 2010 ONLY AND THEY DO NOT HAVE THE PATIENT'S CAUSE OF DEATH OR ANY FURTHER INFORMATION. THE DEATH CERTIFICATE FOR THE PATIENT WAS REQUESTED FROM THE OFFICE OF VITAL RECORDS IN THE STATE THE PATIENT PASSED AWAY IN; HOWEVER, THE OFFICE REPRESENTATIVE STATED THAT THE MANUFACTURER OF THE PATIENT'S IMPLANTED VNS IS NOT ELIGIBLE TO OBTAIN A COPY OF THE PATIENT'S DEATH CERTIFICATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 016250

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death