BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 1810795 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00489
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Date of Event
    December 1, 2005
    Report Date
    July 12, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KHURANA, DIVYA S. ET AL (2005) VAGUS NERVE STIMULATION IN CHILDREN WITH REFRACTORY EPILEPSY: UNUSUAL COMPLICATIONS AND RELATIONSHIP TO SLEEP-DISORDERED BREATHING. AMERICAN EPILEPSY SOCIETY MEETINGS IN WASHINGTON, DC, 2-6.

    Description of Event or Problem · 1

    IT WAS REPORTED A VNS PT "HAD NO CHANGE IN SEIZURE FREQUENCY." GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1