BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 851292 · Received May 3, 2007

    Report

    Report Number
    1644487-2007-00565
    Event Type
    Other
    Date Received
    May 3, 2007
    Date of Event
    March 19, 2007
    Report Date
    April 3, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEATH OCCURRED, BUT IS NOT SUSPECTED TO BE RELATED TO VNS THERAPY. DEVICE MALFUNCTION IS NOT SUSPECTED.

    Description of Event or Problem · 1

    REPORTER INDICATED AN EPILEPSY PT HAD "PASSED AWAY". IT WAS REPORTED THAT IT IS NOT BELIEVED THAT THE EVENT IS RELATED TO THE VNS THERAPY SYSTEM. THE AUTOPSY STATES THE CAUSE OF DEATH IS "SEIZURE DISORDER (SUDEP, SUDDEN UNEXPECTED DEATH OF EPILEPSY), AND THE MANNER OF DEATH IS CLASSIFIED AS NATURAL CAUSES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 14714

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other