BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2081231 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00850
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER SOFTWARE INVESTIGATION, THIS INTERMITTENT TRACKING IS INTENDED BY THE SOFTWARE TO PREVENT IMPACT FROM METAL INTERFERENCE. THIS IS NOT A SOFTWARE DEFECT AND THE SITE SHOULD BE EDUCATED ON PROPER SYSTEM SETUP AND ON INTERPRETING THE RED AND GREEN STATUS CHANGE FROM INSTRUMENTS.

    Description of Event or Problem · 1

    SITE REPORTED INTERMITTENT TRACKING OF THEIR INSTRUMENT ON THE FUSION NAVIGATION SYSTEM. THE THRESHOLD LIMIT ON THE INSTRUMENTS MADE IT SUCH THAT IT WOULD GO TO RED STATUS AND DISCONTINUE TRACKING SO OFTEN. SURGEON CONTINUED WITH NAVIGATION. NO IMPACT ON PT OUTCOME REPORTED.

    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 UNK