BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2160380 · Received June 20, 2011

    Report

    Report Number
    1644487-2011-01383
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 23, 2011
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. 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 VNS PT HAD HIGH LEAD IMPEDANCE WITH DIAGNOSTICS TESTING, AND X-RAYS WERE SENT TO THE MANUFACTURER FOR REVIEW. REVIEW OF THE X-RAYS DID NOT IDENTIFY ANY OBVIOUS LEAD BREAKS, BUT THE LEAD PIN WAS FULLY INSERTED INTO THE GENERATOR HEADER, RULING OUT A LEAD PIN ISSUE AND MAKING A LEAD FRACTURE THE MORE LIKELY CAUSE OF THE HIGH LEAD IMPEDANCE. 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 200631

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR