BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLESTAR N30 SURGICAL MRI SYSTEM

    MDR report key: 6365650 · Received February 28, 2017

    Report

    Report Number
    1723170-2017-00891
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    September 8, 2015
    Report Date
    February 28, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (ISRAEL)
    Product Code
    LNH
    UDI-DI
    00613994719225
    PMA / PMN Number
    K092308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE JOURNAL ARTICLE/AUTHOR. EVENT DATE IS APPROXIMATED AS THE EXACT DATES WERE NOT MADE AVAILABLE. THE RECEIVED DATE, (B)(6) 2015, WAS USED. CITATION: ITURRI-CLAVERO, F., GALBARRIATU-GUTIERREZ, L., GONZALEZ-URIARTE, A., TAMAYO-MEDEL, G., DE ORTE, K., MARTINEZ-RUIZ, A., CASTELLON-LARIOS, K., BERGESE, S.D. (2016). ¿LOW-FIELD¿ INTRAOPERATIVE MRI: A NEW SCENARIO, A NEW ADAPTATION. CLINICAL RADIOLOGY, 71, 1193-1198. HTTP://DX.DOI.ORG/10.1016/J.CRAD.2016.07.003 MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PER ATTACHED ARTICLE, FORWARDED BY A MEDTRONIC REPRESENTATIVE, THE USE OF THE IMAGING SYSTEM WAS REPORTED IN THE STUDY. IN JUNE 2012, THE FACILITY ACQUIRED AN INTRAOPERATIVE MAGNETIC RESONANCE IMAGING (IOMRI) SYSTEM. FROM JUNE 2012 TO APRIL 2014, 109 NEUROSURGICAL PROCEDURES USING IOMRI WERE PERFORMED. THE PROCEDURES INCLUDED GLIOMA (35.77%), PITUITARY ADENOMA (24.77%), AND MENINGIOMA RESECTION (16.51%), AS WELL AS A VARIETY OF INDICATIONS FROM BIOPSIES TO METASTASIS RESECTIONS AND BRAIN ABSCESS DRAINAGE. A TOTAL OF 159 PROCEDURES WERE INCLUDED,109 WERE CRANIAL SURGERIES ASSISTED BY ¿LOW-FIELD¿ IOMRI AND 50 WERE CONTROL CASES (NO IOMRI USED); BOTH GROUPS HAD SIMILAR TUMOUR AETIOLOGIES. TABLE 5 SHOWS THE MEAN TIMES BETWEEN PATIENTS WITH AND WITHOUT THE USE OF IOMRI. PATIENT POSITIONING WHEN USING IOMRI IS AFFECTED BY TECHNICAL REQUIREMENTS AND THE INDIVIDUAL ANTHROPOMETRIC CHARACTERISTICS OF EACH PATIENT. IN ADDITION, DEPENDING ON NECK LENGTH AND SHOULDER WIDTH, THE NEED FOR SHOULDER TRACTION IS DETERMINED, ESPECIALLY IN ADULT PATIENTS. SUCH TRACTION CAN CAUSE RESPIRATORY RESTRICTION, AND ALSO LEAD TO AXILLARY ARTERY OR BRACHIAL PLEXUS COMPRESSION. ALSO, A DOUBLE DOSE OF PARAMAGNETIC CONTRAST MEDIUM IS RECOMMENDED WHEN WORKING WITH A LOW-FIELD IOMRI. THE MEAN TOTAL TIME FOR THE MRI GROUP WAS 71 MINUTES LONGER THAN THE MEAN TOTAL TIME FOR THE NON-MRI GROUP. THERE WERE NO STATISTICAL SIGNIFICANT DIFFERENCES WHEN ANAESTHETIC TIME (P=0.587), AND SURGICAL TIME (P=0.792) WERE COMPARED; HOWEVER, AN IMPORTANT DIFFERENCE WAS SHOWN IN PATIENT POSITIONING TIME (P<0.0009) AND TOTAL DURATION OF THE PROCEDURE (P<0.0009) BETWEEN THE TWO GROUPS. POSITIONING TIME, STARTED AT THE END OF ANAESTHETIC TIME UNTIL FIRST INCISION. ALL CASES WITH IOMRI SHOWED ANAESTHETIC INCIDENCES, THIS WAS SOMEWHAT PREDICTABLE GIVEN THE BROAD DEFINITION OF THE TERM. AS AN MRI-COMPATIBLE THERMOMETER WAS NOT AVAILABLE, CONSTANT CORE TEMPERATURE MEASUREMENT WAS NOT POSSIBLE AND WAS ONE OF THE MOST COMMON ANAESTHETIC INCIDENCES. OTHER INCIDENCES INCLUDE: IN ALL IOMRI CASES THE ETT USED WAS NOT THE FIRST CHOICE, MONITORING HAD TO BE INTERRUPTED AT SOME POINT DURING IMAGE ACQUISITION, AND THERE WAS INTERFERENCE WITH ECG RECORDING IN ALL CASES. AN UNEXPECTED, YET FREQUENT EVENT WAS COMPRESSION OF THE BRACHIAL PLEXUS, IN ALL PRONE AND LATERAL CASES; HOWEVER, NO POSTOPERATIVE BRACHIAL NEURAPRAXIA OR ANY OTHER NEUROLOGICAL DAMAGE WAS ASSOCIATED WITH THIS EVENT. NO ADVERSE EVENTS RELATED TO THE ADMINISTRATION OF PARAMAGNETIC CONTRAST AGENTS WERE NOTED. SURGICAL TIME PROLONGATION IS A RISK FACTOR IN THE DEVELOPMENT OF MEDICAL AND SURGICAL COMPLICATIONS. PROLONGED SURGERY EXPOSES THE PATIENT TO GREATER ANAESTHESIA DURATION, WHICH ALSO LEADS TO COMPLICATIONS OF ITS OWN. THE USE OF IOMRI HAS BEEN ASSOCIATED WITH AN INCREASE IN SURGICAL TIME, AND AS DESCRIBED BEFORE, THE PRESENT PROCEDURES SIMILARLY WERE SIGNIFICANTLY LONGER BY A MEAN OF 71 MINUTES COMPARED WITH CONTROLS. MOST OF THIS TIME WAS USED TO POSITION THE PATIENT (58 MINUTES), WHICH IS 81.6% OF THE TOTAL AMOUNT OF TIME. BASED ON THE BROAD DEFINITION OF THE TERM ¿ANAESTHETIC INCIDENCES¿, AT LEAST ONE ANAESTHETIC INCIDENCE WAS RECORDED IN EVERY PROCEDURE. ALTHOUGH MOST WERE LIMITED TO MATERIAL SELECTION, THE PERIODS WHEN THE IMAGE ACQUISITION REDUCED MONITORING CAPABILITY WERE ALSO TAKE INTO CONSIDERATION. THE NOISE LEVEL GENERATED BY THE PSN30 IS 98.6 DB AND UP TO 123 DB AT TIMES. IT IS SUGGESTED THAT PATIENTS MAY NEED PROTECTION, ESPECIALLY IN CONSCIOUS PROCEDURES, WHEN THE LEVELS EXCEED 100 DB. IN CONCLUSION, THE INTRODUCTION OF ¿LOW-FIELD¿ IOMRI TO THE NEUROSURGICAL ORS IMPLIES AN INCREASED TIME IN THE SURGICAL PROCEDURE, MOSTLY DUE TO PATIENT POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147691 POLESTAR N30 SURGICAL MRI SYSTEM SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH MEDTRONIC NAVIGATION, INC. (ISRAEL) POLESTAR 00613994719225

    Patients

    Seq Age Sex Outcome Treatment
    1