BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 1922586 · Received November 19, 2010

    Report

    Report Number
    1723170-2010-00087
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED FROM THE SITE AFTER AN ENT CASE THAT THE SCREEN FLASHED BACK FOR 5 SECONDS DURING THE PROCEDURE. HE REPORTED THAT THE INCIDENT OCCURRED WHEN THEY WERE SWITCHING SIDES (DOCTOR WAS NOT NAVIGATING WITH A PROBE). THE SCREEN DISPLAYED FULL SCREEN VIDEO WHEN THIS HAPPENED. THE SYSTEM BEHAVIOR DID NOT HARM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM STEREOTAXIC SYSTEM (HAW) HAW MEDTRONIC NAVIGATION FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK