BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION COMPACT

    MDR report key: 12701161 · Received October 26, 2021

    Report

    Report Number
    1723170-2021-02570
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    October 21, 2021
    Report Date
    April 21, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    PGW
    PMA / PMN Number
    K153247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: THE LOT NUMBER OF PRODUCT ID: 9731203 WAS RECEIVED. THE LOT NUMBER IS 0400009734. THE LOT NUMBER OF PRODUCT ID: 9735546 WAS RECEIVED. THE LOT NUMBER IS 160325. H3/H6: THE EMITTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE REPORTED ISSUE COULD NOT BE REPLICATED AND NO ISSUES WERE OBSERVED. CODES B01, C19 AND D14 ARE APPLICABLE TO THIS ANALYSIS. THE ELECTROMAGNETIC LOCALIZATION SYSTEM CABLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE LEMO CONNECTOR ON THE RETURNED CABLE HAD BEEN DAMAGED, NOT ALLOWING CONNECTION TO THE MATING CONNECTOR. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO PHYSICAL DAMAGE. CODES B01, C07 AND D02 ARE APPLICABLE TO THIS ANALYSIS. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM WAS FUNCTIONING AS INTENDED AND NO ISSUE WAS DETECTED. CODES B01, C19 AND D14 ARE APPLICABLE TO THIS SYSTEM CHECKOUT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 9735546. A MANUFACTURER REPRESENTATIVE WAS LATER ABLE TO TROUBLESHOOT AND NOTED THERE WAS NO GREEN LIGHT FOR THE ELECTROMAGNETIC LOCALIZATION SYSTEM AND STILL DID NOT APPEAR AFTER REBOOTING THE SYSTEM. A SPARE ELECTROMAGNETIC LOCALIZATION SYSTEM WAS USED AND IT WAS DETERMINED THAT THE SYSTEM'S COMMUNICATION CABLE NEEDED TO BE REPLACED. 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 BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S EMITTER WAS NOT RESPONDING OR MAKING THE CHIRPING NOISE. IT WAS ALSO SHOWING THAT THE LOCALIZER WAS NOT CONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597868 FUSION COMPACT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC 9735602

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown