BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 22386974 · Received July 2, 2025

    Report

    Report Number
    1723170-2025-02589
    Event Type
    Death
    Date Received
    July 2, 2025
    Date of Event
    May 9, 2025
    Report Date
    July 2, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    DOI: 10.3171/2025.1.PEDS24387. SUMMARY: OBJECTIVE STEREOTACTIC LASER ABLATION (SLA) OR LASER INTERSTITIAL THERMAL THERAPY (LITT) IS AN EMERGING ALTERNATIVE TO CONVENTIONAL SURGERY FOR CNS TUMORS. FURTHER CHARACTERIZATION OF ITS EFFECTIVENESS AND SAFETY IN THE PEDIATRIC POPULATION IS NEEDED. METHODS A REVIEW WAS CONDUCTED ACCORDING TO PRISMA GUIDELINES USING THE PUBMED/MEDLINE, SCOPUS, EMBASE, GOOGLE SCHOLAR, AND SCIENCE DIRECT DATABASES TO INVESTIGATE THE EFFECTIVENESS AND SAFETY IN THE USE OF LITT TO TREAT PEDIATRIC CNS TUMORS IN CHILDREN. RESULTS A TOTAL OF 24 ARTICLES MET THE INCLUSION CRITERIA. FROM THE 4 RETROSPECTIVE STUDIES COMPRISING 97 PATIENTS (MEAN AGE 11.4 YEARS, 55.0% MALES IN THE POOLED PREVALENCE), THE MOST COMMON TUMOR TYPES WERE PILOCYTIC ASTROCYTOMA (31.5%) AND SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA; 68.5%). TUMORS WERE PRIMARILY LOCATED IN THE FRONTAL LOBE (29.7%) AND THALAMUS (24.4%). POSTOPERATIVE COMPLICATIONS INCLUDED TRANSIENT NEUROLOGICAL DEFICITS IN 12.1% AND PERMANENT DEFICITS IN 6.0% OF PATIENTS. AT A MEAN FOLLOW-UP OF 43.9 MONTHS, MASS REDUCTION WAS OBSERVED IN 68.8% OF PATIENTS AND OVERALL DISEASE IMPROVEMENT IN 91.9% OF PATIENTS, AND THE MORTALITY RATE WAS 2.6%. FROM THE 20 CASE REPORTS/SERIES INVOLVING 67 PATIENTS (MEAN AGE 10.8 ± 4.7 YEARS, 52.2% MALES), THE MEAN TUMOR SIZE WAS 15.7 ± 8.7 CM3. PREDOMINANT TUMOR SUBTYPES WERE PILOCYTIC ASTROCYTOMA (29.9%) AND SEGA (16.4%). TUMORS WERE LOCATED IN ELOQUENT AREAS IN 61.3% OF CASES, NOTABLY THE THALAMUS (24.2%) AND VENTRICULAR SYSTEM (24.2%). PRIOR TREATMENTS INCLUDED SURGERY (78.8%), CHEMOTHERAPY (51.5%), AND IMMUNOTHERAPY (27.3%). KEY LITT PARAMETERS WERE DURATION (7.2 ± 8.8 MINUTES), DOSE (10.2 ± 2.4 W), AND EXTENT OF TUMOR VOLUME DECREASE (68.3% ± 30.4%). THE MOST COMMONLY USED LITT SYSTEM WAS VISUALASE (95.7%). POSTOPERATIVE COMPLICATIONS WERE REPORTED IN 26.9% OF PATIENTS, INCLUDING TRANSIENT NEUROLOGICAL DEFICITS (55.6%), PERILESIONAL EDEMA (22.2%), AND HYDROCEPHALUS (22.2%). HOSPITAL STAYS WERE = 3 DAYS IN 92.7% OF PATIENTS. TUMOR SIZE REDUCTION WAS ACHIEVED IN 86.7% OF PATIENTS, AND 78.9% EXPERIENCED DISEASE IMPROVEMENT. COMPARATIVE ANALYSIS SHOWED THAT A GREATER EXTENT OF ABLATION WAS ASSOCIATED WITH A REDUCED NEED FOR SECONDARY SURGERY (P = 0.038, OR 0.94) AND IMPROVED DISEASE OUTCOMES (P = 0.023, OR 1.05). LONGER LITT DURATION WAS SIGNIFICANTLY ASSOCIATED WITH POSTOPERATIVE COMPLICATIONS (P = 0.050). CONCLUSIONS LITT APPEARS EFFECTIVE IN REDUCING TUMOR SIZE AND IMPROVING DISEASE OUTCOMES IN PEDIATRIC CNS TUMORS. THE LONG-TERM EFFECTIVENESS OF LITT IN PEDIATRIC BRAIN TUMORS REQUIRES FURTHER RANDOMIZED PROSPECTIVE INVESTIGATION. REPORTED EVENT(S): THIS ARTICLE DOCUMENTED REVIEW OF 24 ARTICLES THAT DOCUMENT 20 CASE REPORTS / CASE SERIES AND 4 RETROSPECTIVE STUDIES. THESE REPORTS WERE COMPRISED OF 97 PATIENTS (54.99% MALE, 45.01% FEMALE) WITH A MEAN AGE OF 11.43 YEARS. THE MORTALITY RATE WAS 2.55%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Death