BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL

    MDR report key: 1810714 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00414
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Date of Event
    July 27, 2007
    Report Date
    September 11, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION CANNOT BE RULED OUT. EVENT DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ARTICLE PUBLISHED IN BRAIN AND DEVELOPMENT OFFICIAL JOURNAL OF THE JAPANESE SOCIETY OF CHILD NEUROLOGY. ARTICLE TITLED, COMPARISON OF CORPUS CALLOSOTOMY AND VAGUS NERVE STIMULATION IN CHILDREN WITH LENNOX-GASTAUT SYNDROME WAS RECEIVED AT MFR FOR REVIEW. LACK OF EFFICACY WAS REPORTED IN A PT. NO FURTHER DETAILS KNOWN. NO ADD'L INFO WILL BE PROVIDED BY THE SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1