BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2182400 · Received July 11, 2011

    Report

    Report Number
    1723170-2011-01212
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    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 FINDS THERE WERE NO ISSUES AT POWER UP, THE EMITTER COMMUNICATES AND TRACKS THE INSTRUMENTS THROUGH THE ENTIRE VOLUME. MEDTRONIC REP COULD NOT REPLICATE ISSUE. RMA ISSUED FOR A REPLACEMENT EMITTER.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REP REPORTED AN EMITTER SETTINGS SCREEN, ON A FUSION NAVIGATION SYSTEM, SHOWING RED AND MAKING A LOUD NOISE. COMPONENTS WERE APPROPRIATELY GREEN, THEN WENT FROM RED TO GREEN WHEN REGISTERED. THIS ISSUE DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1