BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 23038023 · Received September 12, 2025

    Report

    Report Number
    1723170-2025-03209
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    April 18, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    AIBAR-DURÁN, J.Á., MIRAPEIX, R.M., GALLARDO ALCAÑI,Z A., SALGADO-LÓPEZ, L., FREIXER-PALAU, B., CASITAS HERNANDO, V., HERNÁNDEZ, F.M., DE QUINTANA-SCHMIDT, C. HIGH-GRADE GLIOMA: COMBINED USE OF 5-AMINOLEVULINIC ACID AND INTRAOPERATIVE ULTRASOUND FOR RESECTION AND A PREDICTOR ALGORITHM FOR DETECTION. J NEUROSURG. 2025. 143(2):323-331. DOI: 10.3171/2024.12.JNS242496. OBJECTIVE: THE PRIMARY GOAL IN NEURO-ONCOLOGY IS THE MAXIMALLY SAFE RESECTION OF HIGH-GRADE GLIOMA (HGG). A MORE EXTENSIVE RESECTION IMPROVES BOTH OVERALL AND DISEASE-FREE SURVIVAL, WHILE A COMPLICATION-FREE SURGERY ENABLES BETTER TOLERANCE TO ADJUVANT THERAPIES SUCH AS CHEMOTHERAPY AND RADIOTHERAPY. TECHNIQUES SUCH AS 5-AMINOLEVULINIC ACID (5-ALA) FLUORESCENCE AND INTRAOPERATIVE ULTRASOUND (IOUS) ARE VALUABLE FOR SAFE RESECTION AND COST-EFFECTIVE. HOWEVER, THE BENEFITS OF COMBINING THESE TECHNIQUES REMAIN UNDOCUMENTED. THE AIM OF THIS STUDY WAS TO INVESTIGATE OUTCOMES WHEN COMBINING 5-ALA AND IOUS. METHODS: FROM JANUARY 2019 TO JANUARY 2024, 72 PATIENTS (MEAN AGE 62.2 YEARS, 62.5% MALE) UNDERWENT HGG RESECTION AT A SINGLE HOSPITAL. TUMOR HISTOLOGY INCLUDED GLIOBLASTOMA (90.3%), GRADE IV ASTROCYTOMA (4.1%), GRADE III ASTROCYTOMA (2.8%), AND GRADE III OLIGODENDROGLIOMA (2.8%). TUMOR RESECTION WAS PERFORMED UNDER NATURAL LIGHT, FOLLOWED BY USING 5-ALA AND IOUS TO DETECT RESIDUAL TUMOR. BIOPSIES FROM THE SURGICAL BED WERE ANALYZED FOR TUMOR PRESENCE AND CATEGORIZED BASED ON 5-ALA AND IOUS RESULTS. RESULTS OF 5-ALA AND IOUS WERE CLASSIFIED INTO POSITIVE, WEAK/DOUBTFUL, OR NEGATIVE. HISTOLOGICAL FINDINGS OF THE BIOPSIES WERE CATEGORIZED INTO SOLID TUMOR, INFILTRATION, OR NO TUMOR. SENSITIVITY, SPECIFICITY, AND PREDICTIVE VALUES FOR BOTH TECHNIQUES, SEPARATELY AND COMBINED, WERE CALCULATED. A MACHINE LEARNING ALGORITHM (HGGPREDICTOR) WAS DEVELOPED TO PREDICT TUMOR PRESENCE IN BIOPSIES. RESULTS: THE OVERALL SENSITIVITIES OF 5-ALA AND IOUS WERE 84.9% AND 76%, WITH SPECIFICITIES OF 57.8% AND 84.5%, RESPECTIVELY. THE COMBINATION OF BOTH METHODS IN A POSITIVE/POSITIVE SCENARIO YIELDED THE HIGHEST PERFORMANCE, ACHIEVING A SENSITIVITY OF 91% AND SPECIFICITY OF 86%. THE POSITIVE/DOUBTFUL COMBINATION FOLLOWED, WITH SENSITIVITY OF 67.9% AND SPECIFICITY OF 95.2%. AREA UNDER THE CURVE ANALYSIS INDICATED SUPERIOR PERFORMANCE WHEN BOTH TECHNIQUES WERE COMBINED, IN COMPARISON TO EACH METHOD USED INDIVIDUALLY. ADDITIONALLY, THE HGGPREDICTOR TOOL EFFECTIVELY ESTIMATED THE QUANTITY OF TUMOR CELLS IN SURGICAL MARGINS. CONCLUSIONS: COMBINING 5-ALA AND IOUS ENHANCED DIAGNOSTIC ACCURACY FOR HGG RESECTION, SUGGESTING A NEW SURGICAL STANDARD. AN INTRAOPERATIVE PREDICTIVE ALGORITHM COULD FURTHER AUTOMATE DECISION-MAKING. REPORTED EVENTS: 85% OF ANY NEW SYMPTOMS WERE TRANSIENT AND IMPROVED AFTER 3 MONTHS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2750124 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention