BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3113451 · Received May 15, 2013

    Report

    Report Number
    1723170-2013-00338
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS UNAVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. A SYSTEM CHECKOUT SHOWED THAT THE EQUIPMENT WAS FULL FULLY FUNCTIONAL. THE SOFTWARE INVESTIGATION FOUND THAT THE PATIENT ARCHIVE WAS NO LONGER AVAILABLE FOR EVALUATION. THE INVESTIGATION WAS UNABLE TO DETERMINE A ROOT CAUSE WITHOUT FURTHER INFORMATION. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN INACCURACY THAT OCCURRED WHILE IN AN ENT PROCEDURE. THE SURGEON FELT INACCURATE BY 1MM OR LESS AFTER PERFORMING THE TRACER REGISTRATION ON THE PATIENT. THE RIGHT SIDE OF THE PATIENT'S HEAD WAS SHOWING EXCLUDED VALUES (RED DOTS/POINTS). TRACER REGISTRATION DID PASS AND THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214633 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR