BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2081127 · Received April 14, 2011

    Report

    Report Number
    1723170-2011-00783
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS TESTED USING A BURT HEAD AND OBTAINED A PREDICTED ERROR OF 1.4MM USING POINTMERGE; REPORTED AS INACCURATE ON THE SEPTUM. RMA ISSUED. SOFTWARE INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT DURING AN ENT CASE, THE SURGEON ALLEGED AN INACCURACY WHILE NAVIGATING. HE PERFORMED A POINTMERGE REGISTRATION AND HAD A PREDICTED ERROR OF 1.2MM. A MEDTRONIC ENT REPRESENTATIVE WAS TROUBLESHOOTING WITH THE SITE, AND TESTED ON A BURT HEAD AND IT WAS STILL INACCURATE. THIS AREA WAS ENCOMPASSED BY THE 1MM ACCURACY SPHERE. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO IMPACT ON THE PATIENT.

    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 55 YR