BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 24345366 · Received February 16, 2026

    Report

    Report Number
    1723170-2026-00247
    Event Type
    Death
    Date Received
    February 16, 2026
    Date of Event
    December 11, 2025
    Report Date
    February 16, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY A2) THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT THE BIOPSY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3) THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE BIOPSY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ACCEPTED DATE. B5) THE ARTICLE CITATION IS INCLUDED. D4) THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. G3) NO 510K PROVIDED AS SYSTEM IS UNKNOWN. H3) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE IS 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

    CITATION: BARCHÉUS, H., CORELL, A., BLOMSTRAND, M., OLSSON BONTELL, T., CARÉN, H., OZANNE, A., JAKOLA, A. S., SMITS, A., LJUNGQVIST, J. (2026). SURGICAL BIOPSY TECHNIQUES IN NEUROSURGERY: A FOUR-YEAR POPULATION-BASED STUDY OF FRAMELESS AND FRAME-BASED PROCEDURES. INTERDISCIPLINARY NEUROSURGERY, 43, 102158. HTTPS://DOI.ORG/10.1016/J.INAT.2025.102158 ABSTRACT: BACKGROUND: SUSPECTED MALIGNANT LESIONS IN THE BRAIN UNAMENABLE FOR RESECTION ARE MOST OFTEN BIOPSIED TO ESTABLISH THE HISTOMOLECULAR DIAGNOSIS, GUIDING FURTHER TREATMENT. HEREIN, WE COMPARE THE POSTOPERATIVE OUTCOMES IN TERMS OF SAFETY AND DIAGNOSTIC YIELD BETWEEN TRADITIONAL AND MORE RECENT BIOPSY TECHNIQUES UTILIZED AT OUR FACILITY. METHODS: POPULATION-BASED PATIENT DATA WAS COLLECTED FROM 2020 TO 2023. PATIENTS WERE SUBDIVIDED DEPENDING ON CHOSEN SURGICAL STRATEGY. DATA INCLUDED CLINICAL, RADIOLOGICAL AND SURGICAL VARIABLES, IN ADDITION TO HISTOPATHOLOGICAL DIAGNOSIS AND POST-OPERATIVE TREATMENT STRATEGY. RESULTS: WE IDENTIFIED 161 ADULT PATIENTS UNDERGOING 163 BIOPSIES; 101 ROBOT-ASSISTED BIOPSIES, 35 FRAMELESS SKULL-MOUNTED TRAJECTORY GUIDED BIOPSIES, 15 BIOPSIES OBTAINED VIA CRANIOTOMIES, AND 12 FRAME-BASED STEREOTACTIC BIOPSIES. THERE WAS NO SIGNIFICANT DIFFERENCE IN DIAGNOSTIC YIELD BETWEEN METHODS, RANGING FROM 94.3 % IN SKULL-MOUNTED BIOPSIES TO 83.3 % IN STEREOTACTIC BIOPSIES. GLIOBLASTOMAS WERE THE MOST COMMON DIAGNOSIS (55.2 %), BUT A PLETHORA OF MALIGNANCIES WERE IDENTIFIED. THE HISTOPATHOLOGICAL DIAGNOSIS WAS INCONCLUSIVE IN 19 PATIENTS (11.7 % OF STUDY POPULATION). ROBOT-ASSISTED AND SKULL-MOUNTED PROCEDURES RESULTED IN SIGNIFICANTLY SHORTER OPERATING TIME COMPARED TO CRANIOTOMIES (P 0.001). THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN RATE OF COMPLICATIONS BETWEEN METHODS. SMALL POSTOPERATIVE HEMORRHAGES WERE DETECTED IN 28.2 % OF CASES (MEDIAN 6 MM), NONE REQUIRED INTERVENTION. SUBSEQUENT ONCOLOGIC TREATMENT WAS ADMINISTERED TO 91.7 % OF PATIENTS WITH A CONCLUSIVE HISTOPATHOLOGICAL DIAGNOSIS, COMPARED TO 73.7 % WITH AN INCONCLUSIVE DIAGNOSIS. CONCLUSION: BOTH FRAMELESS AND FRAME-BASED METHODS DEMONSTRATED COMPARABLE SAFETY AND EFFICACY. ROBOT-ASSISTED BIOPSY WAS THE PREDOM INANT METHOD. OUR FINDINGS FURTHER ILLUSTRATE THE LARGE VARIETY OF HISTOPATHOLOGICAL DIAGNOSES IN PATIENTS PRESENTING WITH RADIOLOGICALLY SUSPECTED BRAIN TUMOR, UNDERSCORING THE IMPORTANCE OF A BIOPSY TO OBTAIN A CONCLUSIVE TISSUE DIAGNOSIS TO GUIDE TREATMENT. REPORTED EVENT: 1. ONE PATIENT WHO RECEIVED POSTOPERATIVE CARE IN ANOTHER HEALTH CARE REGION AND PASSED AWAY 13 DAYS POSTOPERATIVELY (CAUSE OF DEATH UNOBTAINABLE DUE TO HER CONFIDENTIALITY). SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407153 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death