BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 2481266 · Received February 22, 2012

    Report

    Report Number
    1723170-2012-00092
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    IZL
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INSP OF THE DEVICE REVEALED THAT THE ISSUE MAY POTENTIALLY BE RELATED TO THE ELECTRONIC BOARD IN THE X-RAY BATTERIES CHARGING MODULE. A RMA WAS ISSUED FOR THE INVERTER BATTERY CHARGERS OF THE SYS. THE PARTS HAVE NOT BEEN RETURNED TO THE MFR FOR EVAL.

    Additional Manufacturer Narrative · 1

    THE BATTERY CHARGERS WERE REPLACED IN THE SYSTEM AND THIS RESOLVED THE ISSUE. SYSTEM IS NOW FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    THE MEDTRONIC ENGINEER FOUND DURING THE FAILURE ANALYSIS THAT THEY WERE ABLE TO REPLICATE THE ISSUE. ON BOTH BOARDS THEY FOUND COMPONENTS ON THE ELECTRICAL BOARDS SHORTED AND DAMAGED. THE ENGINEER REPORTED: FOUND OUT THAT L1F, C10F WAS BURNED. C10G IS DAMAGED. FAILED CHARGER F OUTPUT TEST PROCEDURE. FAILED CHARGER E OUTPUT TEST PROCEDURE. FOUND OUT THAT D10E WAS BURNED AND SHORTED. REMOVED D10E AND PASSED ON RETEST.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT IT WAS NOT POSSIBLE TO PERFORM 2D FLUORO IMAGES WITH THE O-ARM IMAGING SYS WHILE CEMENT WAS BEING INJECTED INTO THE VERTEBRA DURING A VERTEBROPLASTY PROCEDURE. AS A RESULT, IT WAS NOT POSSIBLE TO MONITOR (INTRA-OPERATIVE) ANY POTENTIAL CEMENT LEAKAGE OUT OF THE VERTEBRAL BODY, HOWEVER, 3D IMAGE ACQUISITION WAS AVAILABLE (POST-OPERATIVE) AND WAS UTILIZED TO CONFIRM ACCURATE CEMENT PLACEMENT. THE PT DID NOT HAVE ANY NEUROLOGICAL DEFICIENCIES, AND THERE WERE NO ADD'L SURGERIES REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-ARM 1000 IMAGING SYSTEM SYSTEM, XRAY, MOBILE (IZL) IZL MEDTRONIC NAVIGATION, INC. BI-700-00027-120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female