BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2062121 · Received March 17, 2011

    Report

    Report Number
    1723170-2011-00671
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION IS IN-PROGRESS AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THIS MESSAGE, 'LOCALIZER NOT CONNECTED', WAS DISPLAYED ON THE BOTTOM OF THE FUSION ENT APPLICATION DURING AN ENT PROCEDURE. SHE EXPLAINED THAT THE SYSTEM FROZE (DISPLAYED RED CROSSHAIRS) WHEN THE ERROR WAS DISPLAYED AND THAT THEY HAD TO GO BACK IN THE APPLICATION ONE TASK AND FORWARD AGAIN TO RESOLVE THIS ISSUE. NAVIGATION SYSTEM WORKED PROPERLY FOR THE REMAINDER OF THE PROCEDURE. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK