BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 4251811 · Received November 14, 2014

    Report

    Report Number
    1723170-2014-01225
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 28, 2014
    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

    MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON RE-EVALUATED THE EVENT AND DEEMED HE MAY NOT HAVE BEEN TOUCHING THE INTERNAL ANATOMY AND THAT THE NAVIGATION SYSTEM WAS ACCURATE. - NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN AN EAR, NOSE & THROAT (ENT) PROCEDURE, THE SURGEON ALLEGED A 4MM INACCURACY, ON THE SURFACE, WHEN CHECKING REGISTRATION ON DEEPER ANATOMY. THE SURGEON RE-REGISTERED THE PATIENT AND DEEMED STILL BEING INACCURATE. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738339 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR