BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1696662 · Received May 21, 2010

    Report

    Report Number
    1644487-2010-01231
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    March 1, 2010
    Report Date
    April 23, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE MEDICAL EXAMINER'S OFFICE THAT THE PT HAD DIED AND THE PHYSICIAN BELIEVES THAT THE DEATH IS A "NATURAL DEATH." THE EXAMINERS OFFICE WANTED TO SEND THE DEVICE BACK FOR ANALYSIS TO MAKE SURE THERE ARE NO PROBLEMS WITH THE DEVICE AS THE FAMILY BELIEVES THE DEATH WAS DUE TO VNS. TREATING PHYSICIAN STATED THAT THE PT "LOST ALL SEIZURE CONTROL" PRIOR TO HIS DEATH AND THEREFORE THEY WANTED TO HAVE THE DEVICE UNDERGO ANALYSIS. ANALYSIS IS CURRENTLY IN PROGRESS FOR THE EXPLANTED PRODUCTS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL TILL DATE. THE CAUSE OF DEATH IS UNK AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200853

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death