BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION COMPACT

    MDR report key: 8134465 · Received December 5, 2018

    Report

    Report Number
    1723170-2018-06066
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 7, 2018
    Report Date
    March 11, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    PGW
    PMA / PMN Number
    K153247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. UDI NOT AVAILABLE FOR THIS SYSTEM AT TIME OF FILING. THE DEVICE WAS NOT RETURNED, SO NO ANALYSIS WAS CONDUCTED. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A SOFTWARE INVESTIGATION ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE THROUGH ARCHIVE/IMAGE ANALYSIS. ANALYSIS FOUND THAT THE PROBABLE CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITHOUT FURTHER INFORMATION. ANALYSIS FOUND THAT THE ANALYSIS WAS INCONCLUSIVE AND PROBABLE CAUSE WAS UNABLE TO BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE LOT NUMBER, UDI AND DEVICE MANUFACTURE DATE WERE PROVIDED. 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 A PROCEDURE. IT WAS REPORTED THAT WHEN DOWNLOADING AN IMAGE THE ERROR MESSAGE "UNABLE TO INTERPRET IMAGE OR HEADER DATA MEDIO IO ERROR" OCCURRED. THE MANUFACTURER REPRESENTATIVE (MR) TRIED DOWNLOADING THE IMAGES WITH ALTERNATE MODULE AND ERROR STILL OCCURRED. THE MR SPOKE WITH IMAGING ON SITE WHO STATING THEY FOLLOWED THE RIGHT PROTOCOL. THE MR CHECKED IF THE CD LOOKS DAMAGED AND IT WASN'T. THE SITE DOWNLOADED A NEW CD TO SEE IF THAT RESOLVED THE ISSUE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. ADDITIONAL INFORMATION REVEALED THAT THE 3RD DISC THAT WAS BURNED WORKED, THE MEDTRONIC REPRESENTATIVE SUSPECTS IT HAS SOMETHING TO DO WITH HOW THE SITE IS BURNING THEIR DISCS. HOWEVER, THE ORIGINAL DISCS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975560 FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC 9735602

    Patients

    Seq Age Sex Outcome Treatment
    1