BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNK

    MDR report key: 1696066 · Received May 20, 2010

    Report

    Report Number
    1644487-2010-01212
    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." IDENTIFIED THAT A VNS PT HAD EXTRUSION OF THE LEAD AT THE GENERATOR SITE THAT CAUSED HYPERTROPHIC SCARRING. THE LEAD EXTRUSION WAS DESCRIBED AS "PARTIAL ESCAPE FROM THE POCKET OF BIPOLAR LEAD IN THE CHEST." NO INTERVENTION FOR THE LEAD EXTRUSION WAS DOCUMENTED IN THE ARTICLE. THE VNS FUNCTION WAS NOT COMPROMISED AS A RESULT OF THE LEAD EXTRUSION PER THE ARTICLE. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R