BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3002493 · Received March 13, 2013

    Report

    Report Number
    1723170-2013-00183
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 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

    THE PATIENT ORIENTATION IN THE SCANNER CAUSED THE SCAN TO BE TILTED L/R. A SIGNIFICANT PORTION OF THE FOREHEAD WAS CUT OFF IN THE SCAN, NOT LEAVING ENOUGH PHYSICAL ANATOMY TO COMPLETE A THOROUGH TRACER REGISTRATION. THE 3D MODEL WAS NOT APPROPRIATE FOR A TRACER REGISTRATION DUE TO THE MISSING ANATOMY. SOFTWARE IS FUNCTIONING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS UNAVAILABLE FROM THE SITE. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A SURGEON BEING 2MM INACCURATE INFERIOR AT THE MIDDLE TURBINATE DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). TRACER WAS USED FOR REGISTRATION TECHNIQUE. THE SURGEON SUCCESSFULLY COMPLETED THE PROCEDURE WITH THE USE OF THE FUSION NAVIGATION SYSTEM. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105774 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR