BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1150730 · Received September 3, 2008

    Report

    Report Number
    1644487-2008-02087
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 31, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRESENTATION CITATION: " EJPN SUPPLEMENT AUTHORS' MEETING-DAY 1" VNS THERAPY IN CHILDREN AND ADOLESCENTS: THE CURRENT STATE OF EVIDENCE"; 2008.

    Description of Event or Problem · 1

    MANUFACTURER REVIEW OF THE CONFERENCE PRESENTATION "EJPN SUPPLEMENT AUTHORS' MEETING-DAY 1, VNS THERAPY IN CHILDREN AND ADOLESCENTS: THE CURRENT STATE OF EVIDENCE" REVEALED A VNS PATIENT HAD INCREASED SEIZURES ABOVE PRE-VNS BASELINE LEVELS. ATTEMPTS TO THE PRESENTER FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other