BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2081179 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00854
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    August 19, 2010
    Report Date
    August 25, 2010
    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

    PER OUR LABELING MITIGATOR IFU STATES WARNING: WARNING - DO NOT OVER TIGHTEN STRAP. ALWAYS LOOK FOR SIGNS OF EXCESSIVE PRESSURE SURROUNDING HEAD FRAME SITE. OVER TIGHTENED STRAPS MAY CAUSE PRESSURE-RELATED INJURIES SUCH AS BRUISING, SKIN MARKS, OR NERVE DAMAGE. MENT REP SPOKE WITH SURGEON ABOUT THE PROPER USE OF HEADSTRAP. NO IMPACT ON PT OUTCOME REPORTED.

    Description of Event or Problem · 1

    SITE REPORTED THAT DURING A SURGERY WITH THE FUSION NAVIGATION SYSTEM, THERE WAS A RED/PURPLE MARK ON THE PT'S HEAD AFTER THE HEAD FRAME WAS REMOVED. THIS WAS THE SITE'S FIRST CASE USING THE HEAD FRAME WITH THE STRAP, AND THEY HAD BEEN TRAINED RECENTLY ON ITS USE PRIOR TO THE CASE. 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