BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1242939 · Received November 21, 2008

    Report

    Report Number
    1644487-2008-02793
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 30, 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 A STUDY PATIENT MADE ONE SUICIDAL GESTURE. PER THE REPORTER, THE GESTURE WAS PURELY MANIPULATIVE AND THERE WAS NO MEDICAL THREAT TO THE PATIENT'S LIFE. IT WAS ALSO INDICATED THAT THE GESTURE WAS PROBABLY RELATED TO THE PATIENT'S MENTAL CONDITION. THE RELATIONSHIP OF THE GESTURE TO VNS IS UNKNOWN AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 011863

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other