BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5960624 · Received September 19, 2016

    Report

    Report Number
    1723170-2016-02093
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Date of Event
    March 30, 2016
    Report Date
    September 19, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450944
    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

    PATIENT INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR, BUT NOT PROVIDED TO DATE. KIM, TERRENCE T., J. PATRICK JOHNSON, ROBERT PASHMAN, AND DONIEL DRAZIN. "MINIMALLY INVASIVE SPINAL SURGERY WITH INTRAOPERATIVE IMAGE-GUIDED NAVIGATION." BIOMED RESEARCH INTERNATIONAL 2016 (2016): 1-7. WEB. ON 5/20/2015 A MEDTRONIC CLINICAL SPECIALIST VISITED THE SITE AND TESTED THE SYSTEM. SYSTEM PASSED ALL HARDWARE, SOFTWARE AND INSTRUMENT TESTING. NO FAULT FOUND. FULLY FUNCTIONAL. REPORTED USABILITY ISSUES ARE RELATED TO USER TECHNIQUE/PATIENT ANATOMY, AND ARE KNOWN INHERENT RISKS OF THIS TYPE OF PROCEDURE. DEVICE PERFORMED AS DESIGNED. INSTRUCTIONS FOR USE PROVIDE PROPER STEPS FOR REFERENCE FRAME SELECTION AND CAMERA POSITIONING. IFU FOR PEDICLE ACCESS KIT NEEDLE (AKA JAMSHIDI NEEDLE) STATE: WARNING: DURING NAVIGATION, VISUALLY CONFIRM NAVIGATIONAL ACCURACY FREQUENTLY BY LOCALIZING ON KNOWN ANATOMICAL POINTS, INCLUDING ACCURACY CHECKPOINTS, AND COMPARING THE POSITION OF THE INSTRUMENT IN THE IMAGE WITH ITS PHYSICAL LOCATION IN SURGICAL SPACE.

    Description of Event or Problem · 1

    ATTACHED JOURNAL ARTICLE, MINIMALLY INVASIVE SPINAL SURGERY WITH INTRAOPERATIVE IMAGE-GUIDED NAVIGATION, BY KIM ET AL, REPORTS MULTIPLE USABILITY COMPLAINTS: "FOR MISS (MINIMALLY INVASIVE SPINAL SURGERY) IN THE LOWER LUMBAR SPINE (L3-S1), WE FOUND THAT THE POSTERIOR SUPERIOR ILIAC SPINE (PSIS) REFERENCE FRAME OFTENTIMES INTERFERED WITH THE TRAJECTORY AND INSTRUMENTS FOR INSERTION OF THE IPSILATERAL PEDICLE SCREWS. AS A RESULT, IN THESE INSTANCES, WE WOULD SELECT A MIDLINE PERCUTANEOUS INCISION DIRECTLY OVER A PROXIMAL SPINOUS PROCESS AND USE THE NAVIGATED SPINOUS PROCESS CLAMP REFERENCE FRAME DIRECTED AWAY FROM THE SURGICAL AREA. PLACEMENT OF THE STEALTHSTATION WORKSTATION (MEDTRONIC, INC.) AND STEALTHSTATION (LED DETECTOR CAMERA) WAS PLACED AT THE FOOT OF THE BED FOR PSIS (POSTERIOR SUPERIOR ILIAC SPINE) FRAMES AND HEAD OF THE BED FOR THE MIDLINE SPINOUS PROCESS REFERENCE FRAME. CAREFUL ATTENTION TO ¿LINE-OF-SIGHT¿ ISSUES FOR THE NAVIGATED REFERENCE FRAME AND STEALTHSTATION PLACEMENT IN THE ROOM ARE TWO EXAMPLES OF INSTRUMENT ISSUES THAT A SURGEON MUST CONSIDER IN ORDER TO MAXIMIZE THE WORKFLOW FOR A NAVIGATED MISS." IN MISS NAVIGATION SURGERY, THERE IS OFTENTIMES NO CLEAR ANATOMIC POINT THAT CAN BE REFERENCED TO DETERMINE NAVIGATION ACCURACY. ESPECIALLY IN MORBIDLY OBESE PATIENTS, BONY SURFACE ANATOMY CAN BE HARD TO PALPATE AND ASSESS. BY OBTAINING A CT IMAGE WITH THE CASPAR PIN INSERTED INTO THE BONY SPINOUS PROCESS, THE SURGEON CAN RELIABLY USE THIS POINT AS A CHECK FOR ACCURACY FOR ALL NAVIGATED INSTRUMENTS (FIGURE 3). PRECISE PLACEMENT OF THE INITIAL JAMSHIDI IS CRITICAL TO ACHIEVING HIGH ACCURACY WITH NAVIGATED MISS PEDICLE SCREWS. ANATOMIC VARIANCES OF DORSAL VERTEBRAL BONE SURFACES AND PEDICLE STARTING POINTS CAN BE IRREGULAR AND DIFFICULT TO DOCK. WE FOUND THAT IT WAS CRITICAL TO INSERT THE NAVIGATED JAMSHIDI AWL IN A VERY LATERAL-TO MEDIAL STARTING TRAJECTORY IN ORDER TO MINIMIZE ¿SLIPPING¿ OFF THE STARTING POINT. IN ADDITION, WE EMPHASIZE INSERTING THE JAMSHIDI WITH MINIMAL PULLING/PUSHING OF SURROUNDING SOFT TISSUE. OUR TECHNIQUE EMPHASIZES THE CONCEPT OF INSERTING THE JAMSHIDI THROUGH THE PARASPINAL MUSCLES LIKE ¿THROWING A DART.¿ MINIMIZING SOFT TISSUE RETRACTION AND MANIPULATION MINIMIZES VARIANCE IN NAVIGATION TRAJECTORY AND ULTIMATELY TRANSLATES INTO MORE ACCURATE PEDICLE SCREWS. IT IS NOTED THAT SIGNIFICANT DOWNWARD FORCES DURING TAP CANNULATION AND SCREW INSERTION CAN BE APPLIED TO THE VERTEBRAL BODY, THEREBY MOVING THE VERTEBRAL BODY FROM ITS ORIGINAL IMAGED POSITION. THIS CAN LEAD TO SIGNIFICANT INACCURACY AND MISPLACED INSTRUMENTATION. CURRENT NAVIGATION TECHNOLOGY IS UNABLE TO ACCOUNT FOR SHIFTS IN VERTEBRAL BODY POSITION AND DYNAMIC CHANGE IN THE SPINAL BONY ANATOMY. AS A RESULT, WE RECOMMEND EXTREME CARE IN MINIMIZING EXTREME FORCES THAT WOULD DISPLACE OR ALTER THE ALIGNMENT OF THE OPERATED SPINE. MANAGEMENT OF GUIDE WIRES DURING NAVIGATED MISS IS EXTREMELY CRITICAL. AS THERE IS NO ABILITY TO NAVIGATE THE TIP OF THE GUIDE WIRE IN REAL TIME, THERE IS A THEORETICAL RISK OF INADVERTENTLY PUSHING THE GUIDE WIRE THROUGH THE VERTEBRAL BODY AND INTO THE ABDOMINAL CAVITY. IN OUR TECHNIQUE, DURING NAVIGATED MISS, WE PAY SPECIAL ATTENTION TO GUIDE WIRE LOCATION. AFTER A CANNULATED INSTRUMENT OR SCREW IS STARTED IN THE PROXIMAL PEDICLE, WE RECOMMEND PULLING THE GUIDE WIRE BACK SEVERAL INCHES.THIS ESSENTIALLY ELIMINATES THE POSSIBILITY OF INADVERTENT GUIDE WIRE ADVANCEMENT. ¿GUIDE WIRELESS¿ NAVIGATED MISS TECHNIQUES HAVE ALSO BEEN PREVIOUSLY DESCRIBED [24]. THE REVERSE-PROJECTION OPTION ON THE STEALTHSTATION COMPUTER SCREEN ALLOWS FOR SAVING OF PEDICLE TRAJECTORY WITHOUT GUIDE WIRES. HOWEVER, WE FOUND THAT USING GUIDE WIRES WAS MUCH MORE REPRODUCIBLE AND RELIABLE AND LED TO FASTER DELIVERY OF PEDICLE TAPS, SCREWS, AND OVERALL SURGERY. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613427 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1