BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUALASE

    MDR report key: 22342939 · Received June 26, 2025

    Report

    Report Number
    1723170-2025-02503
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    February 8, 2025
    Report Date
    November 5, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    GEX
    UDI-DI
    00643169905719
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E0107: BEHAVIORAL CHANGES E0120: MEMORY DEFICITS E0839: HEMIANOPSIA E2401: HYPONATREMIA G2: THIS EVENT OCCURRED IN SPAIN, 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.

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION WAS ADDED TO B5. 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

    H2, H6: FDD CODE UPDATED H2, D1-D4: SYSTEM INFORMATION 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.

    Description of Event or Problem · 0

    CITATION: ACTA NEUROCHIRURGICA (2025) 167:39 HTTPS://DOI.ORG/10.1007/S00701-025-06429-3 SUMMARY: BACKGROUND: MAGNETIC RESONANCE IMAGING GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRIGLITT) IS A PROMISING TREATMENT FOR DRUG-RESISTANT EPILEPSY (DRE) AND AN ALTERNATIVE TO OPEN SURGERY. HOWEVER, THE RELATIONSHIP BETWEEN CLINICAL AND RADIOLOGICAL FACTORS AND POSTOPERATIVE OUTCOMES IS UNCLEAR. THIS STUDY EXPLORES THE INDICATIONS, TECHNICAL CHALLENGES, AND OUTCOMES OF MRIGLITT IN TERMS OF SEIZURE CONTROL AND COGNITIVE CHANGES ACROSS VARIOUS PATHOLOGIES. METHODS: A RETROSPECTIVE SINGLE-CENTER ANALYSIS INCLUDED 32 MRIGLITT PROCEDURES PERFORMED BETWEEN JANUARY 2019 AND DECEMBER 2023. PROCEDURES USED THE VISUALASE ® SYSTEM FOR LASER ABLATION, WITH STEREOTACTIC ROBOTIC GUIDANCE FOR FIBER PLACEMENT. DATA INCLUDED DEMOGRAPHICS, CLINICAL AND SURGICAL DETAILS (ABLATED VOLUME, TIMING, POWER AND ACCURACY), AND POSTOPERATIVE FOLLOW-UP ASSESSED SEIZURE OUTCOMES AND COMPLICATIONS. COGNITIVE CHANGES WERE ANALYZED USING A RELIABLE CHANGE INDEX (RCI) BEFORE AND ONE YEAR AFTER THE PROCEDURE. RESULTS: THE 32 PROCEDURES INVOLVED 28 PATIENTS WITH MRI-DIAGNOSED PATHOLOGIES: 14 HIPPOCAMPAL SCLEROSIS (HS), 7 HYPOTHALAMIC HAMARTOMA (HH), 3 FOCAL CORTICAL DYSPLASIA (FCD), 2 PERIVENTRICULAR HETEROTOPIA (PVH), 1 TUBEROUS SCLEROSIS COMPLEX (TSC), AND 1 LOW-GRADE GLIOMA. SOME CASES REQUIRED MULTIPLE APPROACHES. POSTOPERATIVE FOLLOW-UP AVERAGED 33 MONTHS. AMONG HS PATIENTS, 71.42% ACHIEVED ENGEL I, AND 21.43% ENGEL II. IN HH, 85.7% INITIALLY BECAME GELASTIC SEIZURE-FREE, WITH COMPLETE FREEDOM AFTER ADDITIONAL TREATMENT. ENGEL I OUTCOMES WERE 28.6%, WHILE 57.2% SHOWED SIGNIFICANT IMPROVEMENT (ENGEL I + II). FCD PATIENTS HAD A 66.6% ENGEL I SUCCESS RATE. ONE PVH PATIENT BECAME SEIZURE-FREE, WHILE THE TSC PATIENT WAS ENGEL III AT LAST FOLLOW-UP. RCI ANALYSIS SHOWED THAT 71.44% OF PATIENTS EXPERIENCED COGNITIVE STABILITY (RCI > -1.64) OR IMPROVEMENT (RCI > 1.64) AT ONE-YEAR POST-PROCEDURE. CONCLUSIONS: MRIGLITT IS A SAFE, MINIMALLY INVASIVE ALTERNATIVE FOR EPILEPSY SURGERY, OFFERING QUICKER RECOVERY AND SHOWING BETTER PERFORMANCE PRESERVING COGNITIVE FUNCTION. IT IS PARTICULARLY EFFECTIVE FOR DEEP OR COMPLEX EPILEPTIC FOCI AND PATIENTS WHO MIGHT REFUSE OPEN SURGERY. REPORTED EVENTS: THIS ARTICLE STUDIED 28 PATIENTS (16 MALE, 12 FEMALE). THE AVERAGE AGE AT SURGERY WAS 37.21 YEARS. THE MEAN ERROR AT THE ENTRY POINT WAS 1.33 MM (EUCLIDEAN DISTANCE) AND 1.28 MM (RADIAL DISTANCE). THE ACCURACY OF THE FINAL ABLATED VOLUME IDENTIFICATION REMAINS UNCLEAR, TWO CASES EXPERIENCED COMPLICATIONS RELATED TO THE TREATMENT (6.25% PER PROCEDURE). IN ONE PATIENT TREATED WITH A MESIAL TEMPORAL ABLATION, HEMIANOPSIA WAS NOTED DUE TO HEAT SPREADING POSTERIORLY BEYOND THE PLANNED TARGET, AFFECTING THE OPTIC RADIATION. ONE CASE, AMONG THE HH GROUP (10% PER PROCEDURE) DEVELOPED HYPONATREMIA, BEHAVIORAL CHANGES, AND MEMORY DEFICITS, AS PREVIOUSLY MENTIONED, THAT RESOLVED OVER WEEKS. THERE WERE NO INSTANCES OF HEMORRHAGE, INFECTION, OR CEREBROSPINAL FLUID LEAKAGE. ALL PATIENTS WERE DISCHARGED WITHIN 24¿48 H AFTER THE PROCEDURE.

    Description of Event or Problem · 0

    THE MEDTRONIC PRODUCT MENTIONED IS THE VISUALASE SYSTEM. THE ADVERSE EVENTS REPORTED IN THE ARTICLE ARE RELATED TO THE PROCEDURAL TECHNIQUE RATHER THAN DIRECT DEVICE MALFUNCTIONS. SPECIFICALLY, THE COMPLICATIONS APPEAR TO BE ASSOCIATED WITH HEAT DIFFUSION AFFECTING SURROUNDING TISSUES DURING THE ABLATION PROCESS. NO DEVICE DEFECTS OR FAILURES HAVE BEEN IDENTIFIED AS THE CAUSE OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803367 VISUALASE POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. 9735542 00643169905719

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Hospitalization| R