BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 6075627 · Received November 3, 2016

    Report

    Report Number
    1723170-2016-03427
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    September 14, 2015
    Report Date
    November 3, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE IMAGING SYSTEM EQUIPMENT. THE IMAGING SYSTEM PASSED THE SYSTEM CHECKOUT. THE LOGS SHOW THE 3D SPIN WAS TERMINATED DUE TO LOSS OF NAVIGATION. COULD NOT DUPLICATE REPORTED ISSUE. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. NO PARTS RECEIVED BY MANUFACTURER. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE (B)(6) DISTRICT OFFICE ON (B)(6) 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 (B)(4). THIS REVIEW WAS PERFORMED AS A RESULT OF RECENT CHANGES/IMPROVEMENTS TO THE MEDTRONIC NAVIGATION, INC. MEDICAL DEVICE REPORT (MDR) REVIEW PROCESS AND IS FOR NON-ADVERSE EVENT REPORTABLE MALFUNCTIONS WITHIN THE LAST TWO YEARS WHERE THE REPORTED MALFUNCTION WAS NOT PREVIOUSLY ASSOCIATED WITH SERIOUS INJURIES. SIMILAR MALFUNCTIONS THAT HAD RESULTED IN SIGNIFICANT DELAYS OF SURGERY OR REQUIRED ADDITIONAL INTERVENTION HAD BEEN REPORTED AS MDR SERIOUS INJURIES. BASED ON THIS 483 OBSERVATION, THE REPORTING DETERMINATION HAS BEEN REVISED TO CONSIDER THESE MALFUNCTION EVENTS REPORTABLE. THIS PROCESS CHANGE RESULTED IN AN OVERALL INCREASE IN THE NUMBER OF MDRS FILED BY MEDTRONIC NAVIGATION, INC., SINCE APRIL 2016. IT SHOULD BE NOTED THAT THIS INCREASE IS NOT THE RESULT OF THE DISCOVERY OF NEW PRODUCT PROBLEMS, BUT RATHER THE RESULT OF A BROADER INTERPRETATION AND APPLICATION OF THE REGULATIONS WITHIN OUR PROCESSES.

    Description of Event or Problem · 1

    A RADIOLOGIC TECHNOLOGIST (RT) REPORTED THAT THEY WERE UNABLE TO ACQUIRE POST-OP 3D SPIN DURING A SPINAL FUSION. THEY HAD USED THE IMAGING SYSTEM SUCCESSFULLY FOR A PRE-OP SPIN IN TWO DIFFERENT ROOMS PRIOR TO ISSUE. THE RT WAS INFORMED THAT THE IMAGING SYSTEM DID NOT RESPOND WHEN THE TECH USED THE FOOTSWITCH. THE SURGEON WAS ABLE TO SEE WHAT HE NEEDED TO SEE FROM THE AP/LATERAL IMAGE. THE TECH THEN TOOK THE IMAGING SYSTEM INTO ANOTHER ROOM AND WAS ABLE TO ACQUIRE A SUCCESSFUL 3D SPIN. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728199 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00027-120

    Patients

    Seq Age Sex Outcome Treatment
    1