BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION ENT NAVIGATION SYSTEM

    MDR report key: 10396407 · Received August 12, 2020

    Report

    Report Number
    1723170-2020-02151
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    August 10, 2020
    Report Date
    August 28, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT WHILE REGISTERING A PATIENT, THE SURGEON REPORTED THAT THE SYSTEM WAS NOT COLLECTING POINTS. THE SURGEON CLAIMED THAT ONE IN TEN POINTS WERE BEING COLLECTED. THE SITE CHECKED EM INTERFACE AND ALL COILS SHOWED "NAV ERROR". THE SITE REPLACED THE PATIENT AND INSTRUMENT TRACKER, THEN A RED X APPEARED OVER THE EMITTER STATUS IN THE SOFTWARE. POWER CYCLED AND THE EMITTER RECONNECTED. THEY WERE ABLE TO SUCCESSFULLY REGISTER THE PATIENT AND PROCEED. THIS WAS REPORTED PRE-OPERATIVELY OF A FUNCTIONAL ENDOSCOPIC AND SINUS SURGERY PROCEDURE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 20 MINUTES. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859173 FUSION ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733560XOM

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR