BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2081281 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00818
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 29, 2010
    Report Date
    March 29, 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

    MEDTRONIC ENT REP REPORTED THAT THE SYS WAS WORKING PROPERLY. HE WAS ABLE TO TRACK INSTRUMENTS THROUGHOUT THE ENTIRE EM VOLUME (14 INCHES). DISCUSSED WITH SURGEON AND STAFF HOW TO PROPERLY SET UP THE EMITTER AND THE SYS. IT WAS FOUND THAT THE INSTRUMENT WAS BENT, A NEW SUCTION WAS SENT TO SITE AND IT DID SOLVE THE ISSUE. NO RETURN EXPECTED. NO IMPACT ON PT REPORTED.

    Description of Event or Problem · 1

    SITE REPORTED DIFFICULTY TRACKING AND VERIFYING INSTRUMENTS DURING A CASE. THEY INITIALLY GOT THE INSTRUMENTS TO VERIFY AND REGISTERED THE PT WITHOUT ISSUE. HOWEVER, WHEN TRACKING, THE FRAZIER SUCTION WOULD TRACK AWAY FROM THE PT'S NOSE NOT ON THE PT'S NOSE. THEY CONFIRMED THAT THE EMITTER WAS NOT PLACED TOO CLOSE, CAUSING THE SUCTION NOT TO THE TRACKED. THEY REPORTED RED CROSSHAIRS AND COULDN'T TRACK, THEY TRIED RE-VERIFYING THE PROBES AND THEY GOT HIGH DISTANCE TO DIVOT ERRORS. THE SURGEON PROCEEDED WITHOUT NAVIGATION. NO IMPACT TO PT OUTCOME WAS 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