BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION COMPACT

    MDR report key: 8647875 · Received May 28, 2019

    Report

    Report Number
    1723170-2019-02725
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    June 7, 2017
    Report Date
    May 28, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    PGW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    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 DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE COMPACT MONITOR WAS NOT RECOGNIZING AXIEM BOX. THE ISSUE WAS RESOLVED WHEN THE MONITOR AND AXIEM WERE POWERED DOWN. THE AXIEM WAS THEN DISCONNECTED FROM THE MONITOR AND BOTH SYSTEMS WERE POWERED BACK ON AND PLUGGED THE AXIEM BACK INTO THE MONITOR. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438498 FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC 9735602

    Patients

    Seq Age Sex Outcome Treatment
    1