BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPORT XT

    MDR report key: 1032232 · Received April 18, 2008

    Report

    Report Number
    1220452-2008-00026
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 9, 2008
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DXE
    PMA / PMN Number
    K061958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVAL. THE PRELIMINARY ENGINEERING ANALYSIS HAS INDICATED THAT THIS EVENT IS CONSIDERED TO BE A REPORTABLE EVENT. THE MADE AWARE DATE IS 2008. ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE COMPLETED. DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE ACTUAL DEVICE USED DURING THE CASE WAS RETURNED. THE INITIAL ENGINEERING ANALYSIS INDICATED THAT THIS EVENT IS NOW CONSIDERED TO BE A "REPORTABLE EVENT". THE "MADE AWARE" DATE IS 2008. THE WIRE LUMEN OF THE ASPIRATION CATHETER IS TORN AND THE RADIOPAQUE MARKER BAND IS MISSING. AN ATTEMPT TO OBTAIN ADDITIONAL INFO ABOUT THE CASE HAS BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPORT XT DXE MEDTRONIC INC. NA 0000643570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA