BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 24189931 · Received January 27, 2026

    Report

    Report Number
    1723170-2026-00161
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    September 23, 2025
    Report Date
    April 21, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3) A MEDICAL ASSESSMENT WAS PERFORMED ON THE CASE. THE SOURCE OF THIS COMPLAINT IS A PUBLICATION (JAIKUMAR ET AL., 2025) DESCRIBING A RETROSPECTIVE SINGLE-CENTER STUDY AIMED AT EVALUATING THE AURORA SURGISCOPE SYSTEM FOR MINIMALLY INVASIVE RESECTION OF DEEP-SEATED INTRACRANIAL TUMORS. THE STUDY ANALYZED PATIENT OUTCOMES, PROCEDURAL DETAILS, AND TUMOR VOLUME REDUCTION. THE OPERATING ROOM SETUP INCLUDED THE AURORA SURGISCOPE (INTEGRA LIFESCIENCES), INTRAOPERATIVE ULTRASOUND (BKACTIV; BK MEDICAL-GE HEALTHCARE), INTRAOPERATIVE STEALTHSTATION SURGICAL NAVIGATION SYSTEM (MEDTRONIC), OMNISCIENT TRACTOGRAPHY AND FUNCTIONAL MAGNETIC RESONANCE IMAGING INTEGRATION (OMNISCIENT NEUROTECHNOLOGY; HAYMARKET), AND THE NICO MYRIAD SYSTEM (NICO CORPORATION). THE STUDY DESCRIBES ANALYSIS OF 17 PATIENTS AND THE PATIENT POPULATION CONSISTED OF INDIVIDUALS WITH GLIOBLASTOMA MULTIFORME (GBM) (52.9%), CAVERNOMAS (23.5%), AND OTHER TUMORS. TWO PATIENTS REQUIRED REOPERATIONS FOR RESIDUAL TUMORS (MAJOR). HYDROCEPHALUS (MAJOR) DEVELOPED IN THREE PATIENTS, ONE DUE TO POSTOPERATIVE INTRAVENTRICULAR HEMORRHAGE, ALL REQUIRING SHUNTING WITH FAVORABLE OUTCOMES. AMONG FOUR GBM RECURRENCES, THREE PATIENTS UNDERWENT RETREATMENT: TWO WITH STEREOTACTIC RADIOSURGERY (ONE PATIENT WAS A GBM-RELATED MORTALITY) AND ONE UNDERWENT REPEAT RESECTION SURGERY (MAJOR). PRESENTING DIAGNOSES OF COMPLEX AND INFILTRATIVE TUMORS, AND INHERENT SURGICAL RISK. BASED ON THE EVENT DESCRIPTION AND MEDICAL EXPERTISE, THE HARMS OF NEUROLOGICAL COMPLICATIONS, HYDROCEPHALUS, AND TUMOR RECURRENCE WERE UNRELATED TO THE DEVICE, AS REASONABLY DETERMINED BY THE LACK OF ANY ALLEGATION OF DEVICE FAILURE OR INACCURACY. THE REPORTED COMPLICATIONS ARE ATTRIBUTABLE TO THE INHERENT MEDICAL AND SURGICAL RISKS ASSOCIATED WITH MANAGING COMPLEX, DEEP-SEATED TUMORS. BASED ON THE MEDICAL SAFETY ASSESSMENT OF THIS EVENT, NO FURTHER ACTION IS RECOMMENDED. 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.

    Additional Manufacturer Narrative · 0

    E0117: HYDROCEPHALUS E0139: NEUROLOGICAL COMPLICATIONS E0506: HEMORRHAGE E2015: REPEAT RESECTION F1205: TEMPORARY IMPACT F29: GBM-RELATED MORTALITY H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. PER MEDICAL SAFETY REVIEW, BASED ON THE EVENT DESCRIPTION AND MEDICAL EXPERTISE, THE HARMS OF NEUROLOGICAL COMPLICATIONS, HYDROCEPHALUS, AND TUMOR RECURRENCE WERE UNRELATED TO THE DEVICE, AS REASONABLY DETERMINED BY THE LACK OF ANY ALLEGATION OF DEVICE FAILURE OR INACCURACY. THE REPORTED COMPLICATIONS ARE ATTRIBUTABLE TO THE INHERENT MEDICAL AND SURGICAL RISKS ASSOCIATED WITH MANAGING COMPLEX, DEEP-SEATED TUMORS. 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

    CITATION: HTTPS://DOI.ORG/10.1227/ONS.0000000000001780. SUMMARY: BACKGROUND AND OBJECTIVES: MINIMALLY INVASIVE TUBULAR SYSTEMS MAY IMPROVE OUTCOMES IN DEEP-SEATED AND INFILTRATIVE BRAIN TUMOR MANAGEMENT BY MINIMIZING PARENCHYMAL DISRUPTION AND SURGICAL COMPLICATIONS. WE PRESENT THE INITIAL FEASIBILITY OF USING THE AURORA SURGISCOPE SYSTEM (INTEGRA LIFESCIENCES) FOR REMOVAL OF DEEP-SEATED LESIONS WITH PRELIMINARY ASSESSMENTS OF SAFETY AND EFFECTIVENESS, EMPHASIZING ITS ADVANTAGES IN VISUALIZATION, ERGONOMICS, AND OPERABILITY. METHODS: WE RETROSPECTIVELY ANALYZED DATA FOR OUR PATIENTS UNDERGOING INTRACRANIAL TUMOR RESECTION APPROACHES WITH THE AURORA SURGISCOPE BETWEEN JULY 2019 AND AUGUST 2024. DEMOGRAPHICS, COMORBIDITIES, PROCEDURAL DETAILS, AND OUTCOMES WERE REVIEWED. TUMOR VOLUMES WERE MEASURED PRERESECTION AND POSTRESECTION USING 3-DIMENSIONAL SLICER. RESULTS: SEVENTEEN PATIENTS (MEDIAN AGE = 68 YEARS [IQR: 50-74]; MEN = 70.6%) UNDERWENT RESECTION FOR GLIOBLASTOMA MULTIFORME (GBM) (52.9%), CAVERNOMAS (23.5%), AND OTHER TUMORS. THEMEDIAN PRERESECTION LESION VOLUME WAS 6.6 ML (IQR: 0.8-17.4) COMPRISING 70.6% PRIMARY TUMORS. GBM CASES (66.7% SUBCORTICAL) HAD A MEDIAN TUMOR VOLUME OF 10.8 ML (IQR: 0.7-17.6). FOR ALL CASES, MEDIAN SURGICAL AND ANESTHESIA DURATIONS WERE 181 MINUTES (IQR: 170-250) AND 290 MINUTES (IQR: 249-329), RESPECTIVELY. ESTIMATED BLOOD LOSS WAS 80 ML (IQR: 50-100). GROSS TOTAL RESECTION AND NEAR-TOTAL RESECTION WERE ACHIEVED IN 70.6% AND 11.8%, RESPECTIVELY. FOR GBMS, SURGICAL DURATION WAS 217 MINUTES (IQR: 170-268), ANESTHESIA TIME 300 MINUTES (IQR: 249-329), AND ESTIMATED BLOOD LOSS 100 ML (IQR: 50-100). GROSS TOTAL RESECTION WAS ACHIEVED IN 55.6% AND NEAR-TOTAL RESECTION IN 22.2%. TWO SUBTOTAL RESECTION CASES (1 GBM) REQUIRED REOPERATION. TWO GBM PATIENTS EXPERIENCED NEUROLOGICAL COMPLICATIONS. NO TUMOR RECURRENCES WERE OBSERVED FOR 254 DAYS (IQR: 49-462); WITH GBMS, NO RECURRENCE OCCURRED FOR 154 DAYS (IQR: 28-178). AMONG 4 GBM RECURRENCES, 1 PATIENT WHOSE RECURRENCE WAS MANAGED WITH RADIOSURGERY SUCCUMBED TO THE GBM. CONCLUSION: THE AURORA SURGISCOPE SYSTEM IS A PROMISING TOOL FOR MINIMALLY INVASIVE TUMOR RESECTION, RESULTING IN CONSIDERABLE VOLUMETRIC REDUCTION, HIGH RESECTION SUCCESS RATES, AND FAVORABLE SURVIVAL OUTCOMES. OUR FINDINGS SUPPORT ITS POTENTIAL TO ADVANCE MINIMALLY INVASIVE SUBCORTICAL (DEEP-SEATED) INTRACRANIAL TUMOR MANAGEMENT. RELATED EVENT(S): A TOTAL OF 17 PATIENTS WERE INCLUDED IN THE STUDY, WITH A MEDIAN AGE OF 68 YEARS. 12 WERE MEN, 5 WERE WOMEN. TWO PATIENTS REQUIRED REOPERATION FOR RESIDUAL TUMORS DETECTED ON POSTOPERATIVE IMAGING. ONE PATIENT WITH STR REQUIRED REOPERATION. TWO NEUROLOGICAL COMPLICATIONS WERE NOTED, RELATED TO SURGISCOPE USE. HYDROCEPHALUS DEVELOPED IN THREE PATIENTS, ONE (A BASAL GANGLIA GBM ABUTTING THE VENTRICLE) BECAUSE OF POSTOPERATIVE INTRAVENTRICULAR HEMORRHAGE; ALL REQUIRED SHUNTING AND HAD FAVORABLE OUTCOMES. THREE OF THESE PATIENTS WITH GBM RECURRENCES UNDERWENT RETREATMENT: TWO WITH STEREOTACTIC RADIOSURGERY (ONE EVENTUALLY SUCCUMBED TO GBM-RELATED MORTALITY) AND ONE REQUIRED REPEAT RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention