BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 1963893 · Received December 22, 2010

    Report

    Report Number
    1723170-2010-00215
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HOSP DECLINED TO PROVIDE PT ID OR AGE. THE ISSUE WAS RESOLVED BY RESTARTING THE SOFTWARE.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE SITE WAS EXPERIENCING RED CROSSHAIRS AND COULD NOT NAVIGATE ANY INSTRUMENTS IN AN ENT SURGERY. SURGEON SUCCESSFULLY COMPLETED THE SURGERY WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT TO THE PT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1