BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 22189564 · Received June 11, 2025

    Report

    Report Number
    1723170-2025-02288
    Event Type
    Death
    Date Received
    June 11, 2025
    Date of Event
    January 14, 2025
    Report Date
    June 17, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2, B5: EVENT DETAILS HAVE BEEN UPDATED. 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

    G2: THIS EVENT OCCURRED IN THE NETHERLANDS, SEE SECTION E. H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT NO DEVICES NOR SOFTWARE OF MEDTRONIC WERE USED FOR THESE BIOPSIES.

    Description of Event or Problem · 0

    CITATION: DOI: 10.1002/ACN3.70000. SUMMARY: OBJECTIVE: A SUBSTANTIAL PART OF CENTRAL NERVOUS SYSTEM (CNS) DISORDERS REMAINS UNEXPLAINED, DESPITE VARIOUS NEW AND MINIMALLY INVASIVE DIAGNOSTIC TECHNIQUES. WITHIN THIS RAPIDLY DEVELOPING DIAGNOSTIC FIELD, THE PRECISE ROLE OF BRAIN BIOPSY IS UNKNOWN. WE AIMED TO STUDY THE CLINICAL IMPACT AND SAFETY OF BRAIN BIOPSIES IN UNEXPLAINED CNS DISORDERS. METHODS: IN THIS RETROSPECTIVE COHORT STUDY, WE INCLUDED ALL ADULT PATIENTS WHO WERE REFERRED FOR A DIAGNOSTIC WORK-UP TO OUR ACADEMIC CENTER WITH NEURO-INFLAMMATORY, NEURO-ONCOLOGICAL, AND NEURO-INFECTIOUS EXPERTISE AND UNDERWENT A BRAIN BIOPSY BETWEEN (B)(6) 2010 AND (B)(6) 2023. TYPICAL CASES OF CNS NEOPLASMS AND INFECTIONS WERE NOT ANALYZED. BRAIN BIOPSIES WERE EVALUATED WITH RESPECT TO DIAGNOSTIC AND THERAPEUTIC IMPACT AND COMPLICATION RISK. RESULTS: BRAIN BIOPSY WAS PERFORMED IN 587 PATIENTS. NINETY-FOUR PATIENTS WITH A CNS DISORDER OF UNKNOWN CAUSE, WITH 107 BIOPSIES, WERE ANALYZED (44% FEMALE, MEDIAN AGE 58 YEARS). POSTOPERATIVE DIAGNOSES INCLUDED BRAIN TUMORS/LYMPHOMAS (37/94, 39%), INFLAMMATORY DISORDERS (11/94, 12%), INFECTIONS (8/94, 9%), AUTOIMMUNE ENCEPHALITIS (8/94, 9%), AND PRIMARY ANGIITIS OF THE CNS (4/94, 4%). DIAGNOSTIC YIELD OF BRAIN BIOPSY WAS 62%, INCREASING UP TO 72% AFTER REPEAT BIOPSIES, AS 10 ADDITIONAL PATIENTS WERE DIAGNOSED WITH A BRAIN TUMOR. IN 77% OF PATIENTS, BRAIN BIOPSY CHANGED THE TREATMENT STRATEGY. SYMPTOMATIC INTRACRANIAL HEMORRHAGE OCCURRED IN 4 OF 107 BRAIN BIOPSIES (4%). INTERPRETATION: IN A SELECTED POPULATION OF PATIENTS WITH UNEXPLAINED CNS DISORDERS, CLINICAL IMPACT OF BRAIN BIOPSIES IS HIGH, WHILE BEING RELATIVELY SAFE. A MULTIDISCIPLINARY TEAM APPROACH IS FUNDAMENTAL IN ESTABLISHING OPTIMAL INDICATION FOR BRAIN BIOPSY AND SUBSEQUENT TREATMENT DECISIONS. REPORTED EVENT(S): THIS WAS A RETROSPECTIVE STUDY OF 94 PATIENTS, 41 FEMALE AND 53 MALE. THE AVERAGE PATIENT AGE AT THE TIME OF BIOPSY WAS 58 YEARS. POST-OPERATIVE DEATH WITHIN 30 DAYS OCCURRED IN 3 OF 107 BRAIN BIOPSIES, ALTHOUGH DEATH WAS CONSIDERED CLEARLY BIOPSY-RELATED IN 1 BRAIN BIOPSY, CONCERNING A PATIENT WITH A MASSIVE INTRACRANIAL HEMORRHAGE 5 DAYS POSTOPERATIVELY. IN ONE CASE, DEATH WAS CONSIDERED NOT BIOPSY-RELATED, IN VIEW OF THE LONG DURATION BETWEEN SURGICAL PROCEDURE AND DEATH (29 DAYS), WHEREAS A DIRECT RELATION BETWEEN BRAIN BIOPSY AND DEATH COULD NOT BE RULED OUT IN THE REMAINING PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95758 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Death