BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL

    MDR report key: 1810845 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00420
    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. INCREASE IN SEIZURES WAS REPORTED IN A PT AND IT IS UNK IF THE EVENT WAS OVER THE PRE VNS SEIZURES RATE. NO FURTHER DETAILS KNOWN. NO ADDITIONAL 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