BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HW INTERFACE, ISOC3D/ORBIC

    MDR report key: 2152421 · Received June 28, 2011

    Report

    Report Number
    1723170-2011-01165
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K022414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO NOT PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. PART NOT RETURNED. A REPLACEMENT ISO C 3D HARDWARE INTERFACE HAS BEEN SENT OUT TO THE SITE.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT DURING TESTING OF THE NAVIGATION SYSTEM INTERFACE WITH THE ORBIC ISO C 3D, THE IMAGES WERE TRANSFERRED OVER W/O ISSUE BUT, WHEN A NAVIGATED PROBE WAS INTRODUCED, ACCURACY WAS OFF. WHEN THE PROBE WAS TOUCHING THE BONE MODEL THE CAMERA WAS TRACKING BOTH SUCCESSFULLY, BUT THE SCREEN WAS BLANK (NO ANATOMY WAS SHOWING IN THE AXIAL/CORONAL/SAGITTAL PLANES). WHEN THE PROBE WAS MOVED AWAY FROM THE BONE MODEL BY SEVERAL INCHES, THEY WERE ABLE TO NAVIGATE ON THE AXIAL IMAGE ONLY, HOWEVER, THE NAVIGATION WAS INACCURATE. THERE WAS NO PT PRESENT AS THIS OCCURRED DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HW INTERFACE, ISOC3D/ORBIC STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 0005592381

    Patients

    Seq Age Sex Outcome Treatment
    1