BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1696067 · Received May 20, 2010

    Report

    Report Number
    1644487-2010-01211
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    June 1, 2007
    Report Date
    April 20, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR REVIEW OF THE PUBLISHED JOURNAL ARTICLE ENTITLED "VNS IN DRUG RESISTANT EPILEPSY: PRELIMINARY REPORT ON A SMALL GROUP OF PATIENTS. ITALIAN JOURNAL OF PEDIATRICS, 2010, 36:30. EMILIO FRANZONI, ET AL." NOTED A PT HAD WORSENING SEIZURES WITH VNS, AND MEDICATION WAS ADDED AS AN INTERVENTION. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    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 Required Intervention