BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 1934167 · Received December 8, 2010

    Report

    Report Number
    1723170-2010-00153
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. PER THE REPORTED EVENT, THE SETTINGS WERE ADJUSTED WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A SITE REP REPORTED THAT WHILE IN AN ENT CASE, REGISTRATION AND NAVIGATION WERE GOOD, HOWEVER, THE 2D IMAGES WERE FLIPPED R AND L. THE SETTINGS WERE ADJUSTED AND THE CASE WAS COMPLETED. THERE WAS NO IMPACT ON THE PT OUTCOME.

    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 59 YR