BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION FLEXENT

    MDR report key: 16619535 · Received March 27, 2023

    Report

    Report Number
    1723170-2023-00457
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    March 3, 2023
    Report Date
    March 27, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    PGW
    PMA / PMN Number
    K200723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735762, VRESION #: 2.0.0, UBD: , UDI#: H3) THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. AFTER DISCUSSION WITH THE SITE IT WAS FOUND THAT THE CABLES WERE PLACED ONTO THE FLAT EMITTER. THIS CAUSED INTERFERENCE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE FIRST OCCURRENCE OF INTERFERENCE WITH ANESTHESIA WAS ON FRIDAY, MARCH 3RD WITH DR. KIM WITH A PATIENT WHO HAD A PACEMAKER. ON MONDAY, MARCH 6TH THIS HAPPENED AGAIN, THIS PATIENT DID NOT HAVE A PACEMAKER. TO THE MANUFACTURER REPRESENTATIVES UNDERSTANDING, THEY WERE BOTH STANDARD FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) CASES. THE SITE¿S CONCERNS WAS ¿AFTER PLACING THE EMITTER UNDER THE PATIENT¿S HEAD, THEY COULD NO LONGER DETERMINE WITHOUT A DOUBT IF THE PACEMAKER WAS FIRING PROPERLY DUE TO THE AMOUNT OF INTERFERENCE. IT WASN¿T UNTIL THE END OF THE CASE WHEN THEY COMPLETELY REMOVED THE EMITTER FROM UNDER THE PATIENT¿S HEAD THAT THE ECG WAS WITHOUT INTERFERENCE¿. THE SITE SEEMED TO THINK THE FLAT EMITTER WAS CAUSING INTERFERENCE WITH THE ECG MONITOR. THEY ALSO MENTIONED THEY WERE INFORMING HEALTH CANADA ABOUT FRIDAY¿S CASE. THE REP ASKED IF THERE WERE ANY INJURIES TO THE PATIENT, AND THEY SAID ALTHOUGH THEY DO NOT FOLLOW UP ON THIS, THEY DID NOT HEAR OF ANY ISSUES WITH RECOVERY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT  THE HEALTH CARE PROFESSIONAL WAS EXPERIENCING A LOT OF INTERFERENCE WITH ANESTHESIA WHILE USING THE FLAT EMITTER AND WAS UNABLE TO USE NAVIGATION. THE PATIENT HAD A PACEMAKER. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS NO ABORTED AND THAT THE HEALTH CARE PROFESSIONAL WAS ABLE TO COMPLETE IT WITH A LOT OF INTERFERENCE. THE PATIENT WAS IMPACTED, BUT THE SITE DID NOT WISH TO PROVIDE THOSE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934681 STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC 9736242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention "SEE H10...."