BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3953669 · Received July 23, 2014

    Report

    Report Number
    1723170-2014-00787
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHIC INFORMATION WAS UNAVAILABLE FROM THE SITE. THE DECISION TO FILE THIS REPORT WAS DERIVED FROM FINDINGS OF AN INTERNAL MANUFACTURER CAPA ADDRESSING DELAY OF THERAPY TO THE PATIENT. A MEDTRONIC REPRESENTATIVE, FOLLOWING UP WITH THE SITE, COMPLETED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    CORRECTION TO DATE REFERENCED IN INITIAL REPORT. INCORRECTLY STATED AS MARCH 2014, SHOULD HAVE READ: COMPUTED TOMOGRAPHY (CT) USED WAS FROM MARCH 2013.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOW PROVIDED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, REGISTERED NURSE (RN), REPORTED THAT WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) THE SURGEON WAS UNABLE TO REGISTER THE PATIENT USING TRACER TECHNIQUE. REGISTRATION POINTS WERE SHIFTING TO THE RIGHT AND IT WAS NOTED THAT THE SURGEON WAS NOT MOVING THE SKIN DURING REGISTRATION. IN TROUBLESHOOTING, THE SITE REPRESENTATIVE EDITED THE 3D MODEL AND ADJUSTED EMITTER POSITION AND STATUS. THE EMITTER SHOWED GREEN STATUS FOR ALL INSTRUMENTS WITH NO METAL WARNING. IT WAS STATED THAT THE COMPUTED TOMOGRAPHY (CT) USED WAS FROM (B)(6) 2014. THERE WAS NO ARTIFACT IN THE SCAN. THE SITE SWITCHED TO POINTMERGE AND ATTEMPTED TO RE-REGISTER, HOWEVER, WAS UNSUCCESSFUL. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430433 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR