BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3243277 · Received July 23, 2013

    Report

    Report Number
    1723170-2013-00540
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO RMAS ISSUED. REPLACEMENT PSU AND CABLE BOTH SHIPPED TO SITE (B)(4) 2013. MEDTRONIC REPRESENTATIVE FOLLOWING-UP AT THE SITE REPORTED THAT THE CAMERA AND CABLE WERE REPLACED THE DAY FOLLOWING THIS EVENT. ALTHOUGH IT WAS REPORTED THAT THERE WERE POWER ISSUES IN THE OPERATING ROOM THAT CAUSED THE ISSUE WITH THE STEALTH, FIRMWARE SOFTWARE WAS UPGRADED TO (B)(4). THE SYSTEM WAS USED IN TWO SUBSEQUENT LUMAR FUSION PROCEDURES WITH NO ISSUES. SUSPECT DEVICES HAVE NOT YET BEEN RETURNED TO MANUFACTURER FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CAMERA CABLE AND CAMERA WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. A VISUAL EXAMINATION DID NOT REVEAL ANY PHYSICAL DAMAGE TO THE CABLE. THE CABLE WAS FULLY FUNCTIONAL AND DID NOT CAUSE THE REPORTED EVENT. WHEN CONNECTED TO KNOWN GOOD SYSTEM THE CAMERA INITIALLY DID NOT POWER UP, THEN DID NOT COMMUNICATE WITH THE SYSTEM CONTROL UNIT (SCU) ONCE IT HAD POWERED UP. THE CAMERA WAS SENT TO THE VENDOR FOR FURTHER EVALUATION. THE CAMERA WOULD NOT POWER ON DUE TO A FAULTY COMPONENT ON THE MAIN BOARD. AS A RESULT THE COMPONENT REQUIRED REPLACEMENT AND RECATHETERIZATION. THE REPORTED EVENT WAS CONFIRMED. THE DEVICE WAS REPLACED AND THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, PRIOR TO THE START OF A NAVIGATED LUMBAR SPINE PROCEDURE, THE NAVIGATION SYSTEM CAMERA WAS BEEPING AND CHANGED TO A RED STATUS. THIS OCCURRED AFTER THE SCRUB TECH VERIFIED ALL INSTRUMENTS WITH NO ISSUES. WHEN GOING FORWARD TO 'ACQUIRE IMAGES' IT WAS NOTED THERE WERE RED X'S FOR COMMUNICATION ON ALL INSTRUMENT CARDS, AND A RED X IN THE CORNER ON THE CAMERA ICON. CHECKED ALL CONNECTIONS AND TURNED THE SCU OFF. RE-CHECKED ALL CONNECTIONS TO CAMERA AND RE-BOOTED SCU WITH NO SUCCESS. ALL THIS TOOK PLACE BEFORE THE SURGEON WANTED TO NAVIGATE. THE SURGEON WAS NOTIFIED THAT NAVIGATION WOULD NOT BE AVAILABLE FOR THIS PROCEDURE. IT WAS REPORTED THAT THERE WERE POWER ISSUES IN THE OPERATING ROOM THAT CAUSED THIS EVENT. THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY WITHOUT THE USE OF NAVIGATION. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344109 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR