BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION COMPACT

    MDR report key: 8685460 · Received June 10, 2019

    Report

    Report Number
    1723170-2019-03140
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    October 3, 2017
    Report Date
    October 24, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    PGW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A HARDWARE ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE. ANALYSIS FOUND COULD NOT BE DUPLICATED. THE AXIEM UNIT WAS CONNECTED TO A TEST SYSTEM WITH THE ENT APPLICATION FOR AN OVERNIGHT BURN-IN TEST. REGISTRATION, TRACKING, AND ACCURACY LOOKED NORMAL ON ALL 8 TOOL PORTS. THEY CONNECTED / DISCONNECTED THE TOOLS FROM EACH PORT MULTIPLE TIMES AND SYSTEM REMAINED FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: MODEL: 9735602, SERIAL/LOT#: UNKNOWN. MODEL: 9660651, SERIAL/LOT#: UNKNOWN. MODEL: 9735546, SERIAL/LOT#: UNKNOWN. MODEL: 9734250, SERIAL/LOT#: UNKNOWN. 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 FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS UNABLE TO COMMUNICATE WITH THE AXIEM BOX. THEY ATTEMPTED TO POWER ON THE NAVIGATION SYSTEM WITHOUT THE AXIEM BOX CONNECTED AND THERE WAS NO CHANGE. A DIFFERENT AXIEM BOX WAS USED AND THERE WAS STILL NO RESOLUTION. THE NUMBER ON THE BOX WAS A 7. THE BOX STATUS WAS UNABLE TO REPORT. THERE WAS NO DELAY TO THE PROCEDURE AND TO IMPACT ON THE PATIENT¿S OUTCOME. THIS ISSUE WAS RESOLVED "WHEN THE MONITOR WAS PLUGGED IN FIRST AND TURNED ON, WE THEN PLUG IN THE ORIGINAL AXIEM BOX AND ALL WORKS/COMMUNICATES JUST FINE."

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS UNABLE TO COMMUNICATE WITH THE AXIEM BOX. THEY ATTEMPTED TO POWER ON THE NAVIGATION SYSTEM WITHOUT THE AXIEM BOX CONNECTED AND THERE WAS NO CHANGE. A DIFFERENT AXIEM BOX WAS USED AND THERE WAS STILL NO RESOLUTION. THE NUMBER ON THE BOX WAS A 7. THE BOX STATUS WAS UNABLE TO REPORT. THERE WAS NO DELAY TO THE PROCEDURE AND TO IMPACT ON THE PATIENT¿S OUTCOME. THIS ISSUE WAS RESOLVED "WHEN THE MONITOR WAS PLUGGED IN FIRST AND TURNED ON, WE THEN PLUG IN THE ORIGINAL AXIEM BOX AND ALL WORKS/COMMUNICATES JUST FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478195 FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC 9735602

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR