BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1051735 · Received May 23, 2008

    Report

    Report Number
    1644487-2008-01205
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT DISPLAYED A SUICIDAL GESTURE. GOOD FAITH ATTEMPTS FOR FURTHER INFO, INCLUDING THE RELATIONSHIP OF THE GESTURE TO VNS THERAPY, ARE CURRENTLY BEING MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 13755

    Patients

    Seq Age Sex Outcome Treatment
    1 Other