BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1744437 · Received June 30, 2010

    Report

    Report Number
    1644487-2010-01521
    Event Type
    Death
    Date Received
    June 30, 2010
    Date of Event
    November 16, 2009
    Report Date
    June 1, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A VNS PT'S CAREGIVER REPORTED TO THE MFR THAT THE PT HAD DIED. ATTEMPTS FOR FURTHER INFO FROM THE TREATING PHYSICIAN ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 009273

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death