BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 7405955 · Received April 8, 2018

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    Report

    Report Number
    1723170-2018-01519
    Event Type
    Malfunction
    Date Received
    April 8, 2018
    Date of Event
    March 16, 2018
    Report Date
    May 14, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURE REPRESENTATIVE INSPECTED THE NAVIGATION SYSTEM ONSITE AND CONFIRMED THE REPORTED ISSUE. THE REPRESENTATIVE WAS ABLE TO REPLICATE THE ISSUE WITH THE DYNAMIC REFERENCE FRAME (DRF) USED IN THE CASE. THE DRF WAS REPLACED AND THE ISSUE RESOLVED. A FULL SYSTEM CHECKOUT WAS PERFORMED AFTER PART REPLACEMENT AND ALL TESTS PASSED. NO PARTS HAVE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CABLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURNED CABLE WAS FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE. THE CABLE PASSED CONTINUITY TESTING WITH NO OPENS OR SHORTS DETECTED. NO PROBLEM WAS FOUND.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A NAVIGATION SYSTEM BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE DYNAMIC REFERENCE FRAME (DRF) WAS FLICKERING. ALL OTHER INSTRUMENTS WERE WORKING NORMALLY, BUT THE DRF CONTINUED TO FLICKER. ANOTHER AXIEM BOX AND EMITTER WERE BROUGHT IN, BUT THE ISSUE CONTINUED. SWITCHING THE AXIEM PORTS, USING DIFFERENT DRFS, AND MOVING THE EMITTER DID NOT RESOLVE THE ISSUE. THERE WAS NO METAL IN THE FIELD. THE SURGEON WAS ABLE TO REGISTER AND CONTINUE TO NAVIGATE WITH THE CONTINUED FLICKERING. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE AND THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248651 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO