BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION COMPACT

    MDR report key: 24483971 · Received March 2, 2026

    Report

    Report Number
    1723170-2026-00332
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 3, 2026
    Report Date
    May 7, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    PGW
    UDI-DI
    00643169789111
    PMA / PMN Number
    K153247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 735546, PRODUCT ID: 9731203, H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3: THE CABLE, LOT NUMBER: 191114, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CABLE FUNCTIONED NORMALLY WITHOUT FAILURE. FLEXING THE UNIVERSAL SERIAL BUS (USB) CABLE DID NOT INDICATE ANY INTERMITTENT OPENS. THE CABLE WAS FULLY FUNCTIONAL. H6: CODES B01, C13, D02 WAS APPLICABLE TO THIS ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H2/H6: RETURN PART: 9731203, LOT NUMBER: 0400008803 WAS RETURNED AND ANALYZED. THERE WAS NO FAILURE FOUND DURING TESTING. CODES B01, C19, AND D14 APPLY. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3, H6: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE AXIEM CABLE AND FIELD GENERATOR WERE REPLACED AND THE SYSTEM THEN FUNCTIONED AS INTENDED. H6: CODES B01, C13, AND D14 ARE APPLICABLE TO THIS ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THERE WAS A SUSPECTED BREAKAGE NOTED IN BOTH THE CABLE AND THE EMITTER. OCCASIONALLY, WHEN TENSION WAS APPLIED TO THE CABLE, INTERRUPTION OF MAGNETIC FIELD GENERATION WAS OBSERVED. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TRACKING MOMENTARILY STOPPED WHILE THE MAGNETIC FIELD WAS BEING GENERATED, AND THEN RECOGNIZED AGAIN. THE CABLE DISCONNECTION OR AN EMITTER MALFUNCTION IS SUSPECTED TO BE THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621390 FUSION COMPACT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC. 9735602 2364341 00643169789111

    Patients

    Seq Age Sex Outcome Treatment
    1