BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O2

    MDR report key: 8485018 · Received April 4, 2019

    Report

    Report Number
    3004785967-2019-00576
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 29, 2019
    Report Date
    May 1, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT ETHERNET PATCH CORD TO STEALTH THAT PREVENTED CONNECTION, ALSO FOUND THAT IOR WAS TURNED ENABLED ON O ARM WHICH MAY CAUSE INTERMITTENT ISSUES. UTILIZED WORKING PATCH CORD, DISABLED IOR IN SYSTEM FEATURES. VERIFIED OPERATION WITH S7 AND TOLD TECHS OF OPERATION WITHOUT IOR DROP DOWN MENU. ACCOUNT DOES NOT HAVE IOR SYSTEM INSTALLED. THE IMAGING SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT INFORMATION UPDATED. PATIENT WEIGHT WAS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA AN FIELD SERVICE ENGINEER (FSE) FROM A RADIATION TECHNICIAN (RT) REGARDING AN IMAGING SYSTEM BEING USED FOR A PROCEDURE. THE RT INDICATED THAT THE IMAGING SYSTEM HAD A CONNECTION ISSUE WITH THE NAVIGATION SYSTEM IN THAT THE SYSTEMS WERE NOT CONNECTING. THE NETWORK CABLE WAS DISCONNECTED FROM THE NAVIGATION SYSTEM AND RECONNECTED WHICH RESOLVED THE ISSUE. THERE WAS NO IMPACT TO PATIENT OUTCOME.

    Description of Event or Problem · 1

    THE ISSUE WAS DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277160 O2 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR