BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 1569758 · Received December 30, 2009

    Report

    Report Number
    1723170-2009-00014
    Event Type
    Injury
    Date Received
    December 30, 2009
    Date of Event
    December 1, 2009
    Report Date
    December 1, 2009
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    IZL
    PMA / PMN Number
    K050996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT AVAILABLE BUT HAS BEEN REQUESTED; THE O-ARM SYSTEM WAS INITIALLY EVALUATED AND REPAIRED AT THE HOSPITAL BY MEDTRONIC SERVICE. THE MALFUNCTION IS AN IMAGE CHAIN COMPONENT FAILURE CAUSING THE IMAGE UPDATE TO THE VIEW STATION TO SLOW DOWN OR BECOME UNRESPONSIVE DURING A FLUOROSCOPIC GUIDED SURGERY (RELATED TO THE SERIOUS INJURY EVENT IN ITS USE OF THE O-ARM'S 2D FLUOROSCOPIC MODE). THE REPLACED COMPONENT IS IN PROCESS OF RETURN TO MEDTRONIC NAVIGATION FOR FURTHER EVAL.

    Description of Event or Problem · 1

    THE MEDTRONIC SALES REP WAS INFORMED BY PHONE FROM THE HEAD OF BIOMED, THAT THE O-ARM IS LOSING CONNECTION FOR SECONDS AFTER EACH 2D ACQUISITION. A 3D ACQUISITION WAS NOT POSSIBLE AT ALL. IT WAS SUGGESTED BY PHONE TO RESTART THE ENTIRE SYSTEM (O-ARM AND MOBILE VIEWING STATION MVS) IN ORDER TO TRY RESOLVING THE COMMUNICATION ISSUE. AFTER REBOOT, 3D AND 2D ACQUISITION WERE POSSIBLE AGAIN. WHEN ARRIVING IN THE OR, THE VERTEBROPLASTY WAS STILL ONGOING. THE SALES REP WAS INFORMED THAT THEY HAD PROBLEMS WITH POOR IMAGE QUALITY IN 2D. EVEN THOUGH IMAGE QUALITY WAS POOR AND NOT USEFUL, THEY STARTED TO INJECT CEMENT INTO THE VERTEBRAL BODY. AS THE SURGEON WAS NOT ABLE TO SEE THE CEMENT FLOW AFTER SOME ADDITIONAL 2D ACQUISITIONS, HE DECIDED TO CHANGE THE IMAGING DEVICE AND THEY BROUGHT IN A TRADITIONAL 2D C-ARM IMAGE INTENSIFIER. NOW, BEING BALE TO SEE THE CEMENT, THEY DISCOVERED SOME CEMENT LEAKAGE INSIDE THE VERTEBRAL FORAMEN. CEMENT HAD TO BE REMOVED IMMEDIATELY IN ORDER TO DECOMPRESS THE SPINAL CORD AND AVOID FURTHER PROBLEMS FOR THE PT. SURGERY TOOK LONGER THAN EXPECTED, ABOUT 1.5 HOURS. NO PT CONSEQUENCE AFTER THE SURGERY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-ARM 1000 IMAGING SYSTEM MOBILE X-RAY SYSTEM (IZL) IZL MEDTRONIC NAVIGATION BI-700-00027 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention