BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW

    MDR report key: 8146714 · Received December 10, 2018

    Report

    Report Number
    1723170-2018-06155
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 23, 2018
    Report Date
    January 7, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169838918
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED DUE TO (B)(6) PATIENT PRIVACY REGULATIONS. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM WAS FUNCTIONING AS INTENDED. THE SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. 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 SURGEON HAD DIFFICULTY WITH TRACING, BUT AFTER COMPLETING POINT MERGE THEY GOT A REALLY GOOD REGISTRATION METRIC. THEY WERE 4MM INACCURATE ON THE SKULL-BASE IN THE SUPERIOR DIRECTION, WHEN THEY WERE TRACKING POSTERIOR THEY FELT IT WAS VERY ACCURATE. THEY ONLY FELT INACCURATE ON THE SKULL-BASE. THE TRACE PATTERN WAS REVIEWED BY TECHNICAL SERVICES (TS) AND WERE FOUND TO BE SUFFICIENT. TS SENT GENERAL RECOMMENDATIONS FOR FUTURE CASES AND TO MEASURE INACCURACIES IN THE FUTURE. THE SITE HAS HAD NUMEROUS SUCCESSFUL CASES SINCE. THERE WAS NO PATIENT IMPACT REPORTED AND A LESS THAN ONE HOUR DELAY TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987450 PGW INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735669 00643169838918

    Patients

    Seq Age Sex Outcome Treatment
    1