BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    MDR report key: 6136746 · Received November 30, 2016

    Report

    Report Number
    1723170-2016-05211
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    May 27, 2015
    Report Date
    November 30, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K092564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER FIELD NOT SUFFICIENT TO HOLD ALL DIGITS, SHOULD READ: (B)(6). PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, THE IMAGES APPEARED DIMINISHED OR GRAYED OUT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. ONSITE INVESTIGATION DISCOVERED THAT THE SYSTEM CALIBRATIONS WERE OVERDUE WHICH CAUSED THE REPORTED EVENT. ISSUE RESOLVED BY PREFORMING SYSTEM CALIBRATIONS. NO FURTHER ISSUES WERE REPORTED. A SOFTWARE INVESTIGATION WAS ALSO COMPLETED. THIS INVESTIGATION FOUND THE REPORTED ISSUE TO BE CAUSED BY USER NOT FOLLOWING MANUFACTURER INSTRUCTIONS AS THE CALIBRATIONS WERE OVERDUE. SOFTWARE FUNCTIONED AS DESIGNED. A FULL IMAGING SYSTEM CHECK-OUT WAS COMPLETED AND ALL TESTS PASSED. FULL SYSTEM FUNCTIONALITY WAS CONFIRMED AND THE SYSTEM WAS RETURNED TO SERVICE. THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW AS DISCUSSED WITH THE FDA NEW ENGLAND DISTRICT OFFICE ON APRIL 7, 2016 VIA MEDTRONIC NAVIGATION, INC. RESPONSE TO 3/17/2016 FDA-483 FEI: 3004785967. 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 MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINAL FUSION PROCEDURE, THE IMAGES APPEARED DIMINISHED OR GRAYED OUT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785739 O-ARM 1000 IMAGING SYSTEM 3RD EDITION IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO MEDTRONIC NAVIGATION, INC. (LITTLETON) BI-700-00028-120

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR