BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1823445 · Received August 25, 2010

    Report

    Report Number
    1644487-2010-01933
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 27, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE LEAD AND GENERATOR CONFIRMED STERILITY PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT HAD A VNS LEAD TIE-DOWN REMOVED DUE TO EXTRUSION. THE AREA WAS REDDENED BUT INFECTION WAS NOT PRESENT. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 2161

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention