BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 21605438 · Received March 14, 2025

    Report

    Report Number
    1723170-2025-01303
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 14, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3, H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MIRZAYEVA, L.S., UÇAR, M., BUDAK, S.N., KAYMAZ, A.M., YAYLI, N. PUSHING THE BOUNDARIES OF NEUROSURGICAL ONCOLOGY: EVALUATING THE SUPERIORITY OF SUPRATOTAL RESECTION OVER GROSS TOTAL RESECTION IN INTRAOPERATIVE MRI-GUIDED GLIOMA SURGERY. NEUROSURGICAL REVIEW. 2025. 48, 200. HTTPS://DOI.ORG/10.1007/S10143-025-03301-X. USING INTRAOPERATIVE MRI (IMRI) IN GLIOMA SURGERY CAN ENHANCE THE EXTENT OF RESECTION (EOR) AND IMPROVE SURVIVAL RATES FOR PATIENTS DIAGNOSED WITH LOW GRADE GLIOMAS (LGG) OR HIGH GRADE GLIOMAS (HGG). THIS STUDY FOCUSED ON PATIENTS WHO UNDERWENT IMRI-GUIDED SURGERY FOR LGG AND HGG AT OUR CENTER. OUR OBJECTIVE WAS TO COMPARE THE PATIENT SURVIVAL TIME AND RECURRENCE RATE BETWEEN SUPRATOTAL RESECTION (SPTR) AND GROSS TOTAL RESECTION(GTR). TO THE BEST OF OUR KNOWLEDGE, THIS IS THE FIRST STUDY COMPARING SPTR WITH GTR USING IMRI IN GLIOMA SURGERY. THIS STUDY INCLUDED 71 PATIENTS WHO HAD UNDERGONE IMRI-GUIDED GTR AND SPTR. THE VOLUME OF THE TUMORS WAS MEASURED USING POSTCONTRAST 3D T1W SERIES AND 3D FLAIR SERIES TAKEN THE DAY BEFORE SURGERY, AND THE VOLUME OF THE OPERATION CAVITY WAS CALCULATED FROM IMRI IMAGES. THE EFFECTS OF SPTR AND GTR ON OVERALL AND PROGRESSION-FREE SURVIVAL (OS AND PFS) WERE ANALYZED BY THE LOG-RANK TEST USING KAPLAN¿MEIER CURVES. THE ASSOCIATIONS BETWEEN THE EXTENT OF RESECTION AND TUMOR GRADE, AND BETWEEN RECURRENCE AND TUMOR GRADE WERE EXAMINED USING THE CHI-SQUARE TEST. THE RATE OF RECURRENCE IN PATIENTS DIAGNOSED WITH HGG WAS GREATER THAN THAT IN PATIENTS DIAGNOSED WITH LGG (P=0.022). WHILE PATIENTS WHO RECEIVED SPTR HAD A GREATER OS TIME (105.9 MONTHS) THAN DID THOSE WHO UNDERWENT GTR (92.8 MONTHS), THE DIFFERENCE WAS NOT STATISTICALLY SIGNIFICANT. THE PATIENTS WITH LGG HAD A SIGNIFICANTLY LONGER PFS TIME THAN DID THE PATIENTS WITH HGG (86.5±5.9 MONTHS, 95% CI=74.9¿98.2, P=0.0001). OF 23 PATIENTS DIAGNOSED WITH HGG, SPTR WAS ACHIEVED IN 9 AND GTR WAS ACHIEVED IN 14. THE MEDIAN OS TIME WAS LONGER IN PATIENTS WHO UNDERWENT SPTR THAN IN THOSE WHO UNDERWENT GTR, BUT THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE [101.2±20.5 MONTHS (95% CI: 80.7¿121.7) VS. 70.6±9.9 (95% CI: 60.7¿80.5) P=0.9]. NEUROSURGEONS ARE INCREASINGLY CHOOSING SPTR, ESPECIALLY IN LGGS. DESPITE THEIR SLOW GROWTH, LGGS RETAIN THE POTENTIAL FOR MALIGNANT TRANSFORMATION. THIS SITUATION UNDERSCORES THE IMPORTANCE OF MAXIMUM SAFE RESECTION IN THE SURGERY OF LGGS. IMRI-GUIDED RESECTION MAKES IT EASIER FOR SURGEONS TO SHOW THE EOR CONCURRENT WITH THE OPERATION. REPORTED EVENTS: ONE PATIENT WITH TINNITUS AND INTERMITTENT DIPLOPIA OBSERVED IN THE FIRST POSTOPERATIVE MONTH. ONE PATIENT WITH RIGHT TEMPORAL HEMIANOPSIA IN A PATIENT OPERATED FOR LEFT OCCIPITAL LGG ONE PATIENT WITH DYSPHASIA LASTING 5 DAYS AFTER SURGERY ONE PATIENT WITH WEAKNESS IN THE LEFT UPPER AND LOWER EXTREMITIES LASTING FOR 1 MONTH AFTER THE SURGERY ONE PATIENT WITH LOSS OF STRENGTH IN THE RIGHT LOWER EXTREMITY (4/5) ONE PATIENT WITH POSTOPERATIVE LOSS OF STRENGTH IN THE RIGHT LOWER EXTREMITY (3/5) ONE PATIENT WITH INCREASED MUSCLE WEAKNESS IN THE UPPER AND LOWER EXTREMITIES COMPARED TO PREOPERATIVE EXAMINATION ONE PATIENT WITH RIGHT SPASTIC HEMIPARESIS NEUROLOGIC DEFICIT WAS DETECTED ION 8 CASES, OF WHICH 6 WERE TEMPORARY AND 2 WERE PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229013 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention