BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GE MODEL 102

    MDR report key: 1993846 · Received February 11, 2011

    Report

    Report Number
    1644487-2011-00245
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 13, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A SLICE C FORM THAT A VNS PT HAD A SUICIDE GESTURE/ATTEMPT. THE EVENT WAS CATEGORIZED AS MODERATE/SERIOUS. AT THE MOMENT THE RELATIONSHIP OF THE SUICIDE ATTEMPT TO VNS THERAPY IS UNK AS GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE TREATING CLINICIAN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GE MODEL 102 LYJ CYBERONICS, INC. 102 14628

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening