BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2062489 · Received March 18, 2011

    Report

    Report Number
    1723170-2011-00678
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION NOT AVAILABLE AT THE TIME OF THE REPORT. EVALUATION OF THE DEVICE HAS NOT YET BEEN PERFORMED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THEY COULD NOT TRACK ON THE DISTAL SIDE OF THE PT'S HEAD. THE INSTRUMENT TRACKER DISPLAYED 4-5. A MEDTRONIC REPRESENTATIVE HELPING TO TROUBLESHOOT HAD THEM RAISE THE EMITTER. THEY COULD TRACK SLIGHTLY FURTHER. THE MEDTRONIC REPRESENTATIVE ASKED IF THEY COULD RAISE THE PT'S HEAD. THEY STATED NO. THE SURGEON OPTED TO DISCONTINUE USE OF THE FUSION NAVIGATION SYSTEM.

    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