BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 6148862 · Received December 6, 2016

    Report

    Report Number
    1723170-2016-05677
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 14, 2016
    Report Date
    June 20, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994380005
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SOFTWARE LOGS WERE COMPLETED. THIS ANOMALY IS TRACKED THROUGH TEST TRACK (B)(4) AND REFERENCES TO THIS CASE HAVE BEEN ADDED TO THAT RECORD.

    Additional Manufacturer Narrative · 1

    PRODUCT, UNIQUE DEVICE IDENTIFICATION (UDI) AND DEVICE MANUFACTURE DATE UPDATED TO PROPER VALUE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT MADE AVAILABLE FROM THE SITE. ON 11/16/2016 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. - NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. - NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT, WHILE IN AN EAR, NOSE & THROAT (ENT) PROCEDURE, THE SITE'S NAVIGATION SYSTEM BECAME UNRESPONSIVE UNEXPECTEDLY. THIS ISSUE OCCURRED MID-PROCEDURE. THE NAVIGATION SYSTEM WAS RE-BOOTED AND NORMAL FUNCTION WAS RESTORED. THE SURGEON OPTED TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800264 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION 00613994380005

    Patients

    Seq Age Sex Outcome Treatment
    1