BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1061889 · Received June 16, 2008

    Report

    Report Number
    1644487-2008-01388
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MANUFACTURER, NO GROSS LEAD DISCONTINUITIES NOTED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A PT HAD A HIGH LEAD IMPEDANCE READINGS AND THAT X-RAYS SHOWED ONE LEAD PIN WAS DISCONNECTED FROM THE GENERATOR HEADER. MANUFACTURER REVIEW OF THE X-RAYS VERIFIED BOTH LEAD PINS WERE FULLY INSERTED AND NO LEAD DISCONTINUITIES WERE IDENTIFIED. ATTEMPTS TO THE REPORTER FOR ADDITIONAL INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 5316

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR