BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1040432 · Received May 9, 2008

    Report

    Report Number
    1644487-2008-01117
    Event Type
    Death
    Date Received
    May 9, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 11, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT HAD PASSED AWAY AND THE CAUSE OF DEATH HAS NOT YET BEEN FINALIZED. THE PATIENT WAS REPORTED TO HAVE BEEN FOUND DEAD ON HIS APARTMENT FLOOR WITHOUT RESPIRATION OR HEART BEAT. THE PATIENT'S DEVICES WERE EXPLANTED AND RETURNED AND ARE CURRENTLY AWAITING ANALYSIS. AT THIS TIME THE TREATING MEDICAL PROFESSIONAL HAS RULED THAT THE DEATH'S RELATIONSHIP TO VNS IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death