BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3941198 · Received July 17, 2014

    Report

    Report Number
    1723170-2014-00767
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SITE DECLINED TO PROVIDE PATIENT DEMOGRAPHIC INFORMATION. FOLLOWING THE PROCEDURE A SECOND REGISTERED NURSE, (B)(6), REPORTED THAT THEY WERE ABLE TO POWER THE SYSTEM ON, ENTER INTO THE SOFTWARE AND LOAD THE PATIENT, HOWEVER, THE SYSTEM WENT INTO POWER SAVE MODE UNEXPECTEDLY. THE PATIENT WAS UNDER ANESTHESIA WHEN THE ISSUE OCCURRED. A MEDTRONIC REPRESENTATIVE CHECKED THE CABLE CONNECTIONS OF THIS SYSTEM AND EVERYTHING WAS SECURE. THE SURGEON SUCCESSFULLY RE-BOOTED THE SYSTEM, LAUNCHED THE APPLICATION AND COMPLETED THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME. REPLACEMENT CPU SHIPPED TO SITE (B)(4) 2014. PART RETURNED TO MANUFACTURER, UNUSED. REPLACEMENT CAMERA SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF SUSPECT DEVICE, RETURNED ON (B)(4) 2014, FINDS THAT THE RETURNED SPRING ARM IS WELL WORN WITH MANY MARKS AND SCRATCHES OVERALL. HOWEVER, THE SPRING ARM CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. NO PROBLEM FOUND. DID NOT CAUSE EVENT. REPLACEMENT CAMERA SPRING ARM ASSEMBLY SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF SUSPECT DEVICE, RETURNED ON (B)(4) 2014, FINDS THAT THE RETURNED PSU WAS FOUND TO BE FULLY FUNCTIONAL WHEN CONNECTED TO A KNOWN GOOD SYSTEM. THE PSU PASSED ALL RRIR TESTING AND WILL RETURN TO SERVICE INVENTORY. NO PROBLEM FOUND. DID NOT CAUSE EVENT. REPLACEMENT TOOL INTERFACE ACC SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF SUSPECT DEVICE, RETURNED ON (B)(4) 2014, FINDS THAT THE RETURNED TOOL INTERFACE UNIT (TIU) WAS FOUND TO BE FULLY FUNCTIONAL WHEN CONNECTED TO A KNOWN GOOD SYSTEM. THE TIU PASSED ALL RRIR TESTING. NO PROBLEM FOUND. DID NOT CAUSE EVENT. REPLACEMENT CPU SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF SUSPECT DEVICE, RETURNED ON (B)(4) 2014, FINDS THAT THE SYSTEM BOOTS TO LOG-IN SCREEN NORMALLY, LAUNCHES AND NAVIGATES SUCCESSFULLY. NO HDD OR RAM ERRORS REPORTED. RUN SYSTEM FOR EXTENDED PERIOD MONITORING FOR REPORTED ISSUE. NO FAULTS ENCOUNTERED, COULD NOT REPLICATE REPORTED ISSUE.. DID NOT CAUSE EVENT. REPLACEMENT TREON MONITOR SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF SUSPECT DEVICE, RETURNED ON (B)(4) 2014, FINDS THAT TESTED THE MONITOR AND FOUND IT TO BE FULLY FUNCTIONAL. DID NOT CAUSE EVENT. REPLACEMENT PARTS: INTERNAL POWER/COMMUNICATION POWER CABLE, TREON COMMUNICATION MONITOR CABLE AND A TREON MONITOR POWER PIGTAIL WERE SHIPPED TO SITE (B)(4) 2014. ALL THREE PARTS WERE RETURNED TO MANUFACTURER, (B)(4) 2014, UNUSED. REPLACEMENT COMMUNICATION POWER CABLE SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF SUSPECT DEVICE, RETURNED ON (B)(4) 2014, FINDS THAT THE RETURNED ASSEMBLY APPEARS TO BE IN GOOD CONDITION. HOWEVER, A CONTINUITY CHECK REVEALED AN OPEN FROM PIN 7 OF THE FISCHER CONNECTOR TO PIN 5 OF THE DB9 CONNECTOR. ELECTRICAL FAILURE - OPENS - DIRECTLY CAUSED EVENT. REPLACEMENT MONITOR CABLE SHIPPED TO SITE (B)(4). MEDTRONIC INVESTIGATION OF SUSPECT DEVICE, RETURNED ON (B)(4) 2014, FINDS THAT THE AUDIO OUT PLUG HAS BEEN BROKEN OFF. OTHERWISE, THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. PHYSICAL DAMAGE - PIECES BROKEN - DIRECTLY CAUSED EVENT. A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT. COMPUTER, CAMERA, SPRING ARM, TIU, EXTERNAL POWER COMMUNICATION CABLE, AND INTERNAL POWER COMMUNICATION CABLE WERE REPLACED. FAILURE RESOLVED. A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, CHECKED THE POWER BUTTON ON THE CPU AND REPORTED IT WAS NOT TURNED ON. ONCE TURNED ON, THE COMPUTER BOOTED NORMALLY AND MONITOR DISPLAY WAS GOOD. THE POWER BUTTON ON THE TIU WAS ALSO POWERED OFF; ONCE TURNED ON THE CAMERA FUNCTIONED PROPERLY. SYSTEM NOW FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, REGISTERED NURSE (RN), REPORTED THAT WHILE LOADING A PATIENT EXAM, THE NAVIGATION SYSTEM UNEXPECTEDLY POWERED OFF. AFTER RE-BOOTING THE SYSTEM, IT WENT INTO POWER SAVE MODE. THIS ISSUE WAS IDENTIFIED PRIOR TO THE START OF THE PROCEDURE. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418994 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1