BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2052087 · Received March 1, 2011

    Report

    Report Number
    1723170-2011-00172
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION NOT AVAILABLE AT THE TIME OF THIS REPORT. PER DISCUSSION BETWEEN THE MEDTRONIC REP AND SURGEON, IT WAS DETERMINED THAT ROTATING THE BLADE IN RELATION TO THE ARRAY CAUSED THE REPORTED EVENT. AFTER SHE EXPLAINED TO HIM THAT HE WOULD NEED TO RE-REGISTER THE BLADE WHEN DOING SO, HIS ACCURACY WAS FINE. THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REP REPORTED THE 40 AND 60 DEGREE BLADES USED WITH THE M4 WERE INACCURATE. THEY RECALIBRATE WHEN THEY SWITCH THE BLADES BUT THE ONLY ONE THAT SEEMS ACCURATE IS THE 4MM TRICUT. THE BLADES ARE SEATED ALL THE WAY IN THE M4. THE SURGEON OPTED TO CONTINUE THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARX EVOLUTION STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. EVOLUTION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK