BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 3212849 · Received July 9, 2013

    Report

    Report Number
    1723170-2013-00501
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. MEDTRONIC REPRESENTATIVE AT THE SITE FOUND THE NAVIGATION SYSTEM SCREEN WAS TOO CLOSE TO THE ENDOSCOPIC SCREEN AND THE ENDOSCOPE WAS ALSO BETWEEN THE EMITTER AND THE TOOL BEING USED (STRAIGHT SUCTION). AFTER REARRANGEMENT OF THE SCREEN AND EMITTER, THE PHYSICIAN WAS ABLE TO COMPLETE THE SURGERY. AFTER FURTHER REVIEW, OTHER CASES THAT THE CUSTOMER DESCRIBED AS "DIFFICULT" WERE MAINLY DUE TO THE STAFF SELECTION OF "CORONAL" SCANS INSTEAD OF THE AXIAL OPTIONS ON THE DISC. THIS INFORMATION WAS REVIEWED, AGAIN, WITH THE OR DIRECTOR AND RN MANAGER. USE ERROR DIRECTLY CAUSED THIS EVENT. FIELD GENERATOR, EMITTER, WILL NOT BE RETURNED TO MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, NURSE, REPORTED THAT, WHILE IN AN ENT PROCEDURE TRACKING WAS INTERMITTENT WHEN USING THE STRAIGHT SUCTION. REGISTRATION WAS ACCURATE AND ONLY SAW FLICKERING WITH THE ONE INSTRUMENT. IN TROUBLE-SHOOTING WITH A MEDTRONIC REPRESENTATIVE, IT WAS DETERMINED THAT THE EMITTER WAS TOO CLOSE AND TRACKING VERY NEAR THE TOP RIGHT CORNER. THE EMITTER WAS MOVED TO A MORE CENTRAL LOCATION FOR TRACKING AND ENSURED THERE WAS NOTHING BETWEEN THE EMITTER AND THE INSTRUMENT. TRACKING IMPROVED. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313258 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR