BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1982446 · Received February 3, 2011

    Report

    Report Number
    1644487-2011-00179
    Event Type
    Death
    Date Received
    February 3, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 5, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY A COMPANY REP THAT A NEUROLOGIST HAD A PT WHO HAD EXPIRED, AND AN AUTOPSY WAS BEING PERFORMED TO CONFIRM THE CAUSE OF DEATH. THE NEUROLOGIST HAD BEEN NOTIFIED OF THE DEATH BY THE PT'S MOTHER. F/U WITH THE PT'S NEUROLOGIST INDICATED THAT THE PHYSICIAN DID NOT KNOW WHO WAS PERFORMING THE AUTOPSY, OR IF HE WOULD BE NOTIFIED OF THE RESULTS. HOWEVER, THE FACILITY PERFORMING THE AUTOPSY WAS LATER IDENTIFIED AND CONTACTED FOR INFO REGARDING THE PT'S DEATH. THE AUTOPSY SITE INDICATED THAT THE AUTOPSY REPORT HAD NOT YET BEEN COMPLETED, AND APPROVAL FROM AN ATTORNEY OR THE NEXT-OF-KIN WOULD BE NEEDED IN ORDER TO RELEASE THE RESULTS. THE FUNERAL HOME WHERE THE PT'S ARRANGEMENTS WERE MADE STATED THE PT'S DEVICE HAD BEEN EITHER DISCARDED OR DESTROYED BEFORE CREMATION. GOOD FAITH ATTEMPTS FOR MORE INFO FROM THE PT'S NEUROLOGIST CONCERNING THE PT'S DEATH AND ITS RELATIONSHIP TO VNS HAVE BEEN UNSUCCESSFUL TO DATE. ALSO, ATTEMPTS TO OBTAIN AN AUTOPSY REPORT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 201326

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Death