BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA®

    MDR report key: 21762518 · Received April 3, 2025

    Report

    Report Number
    9612501-2025-00946
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 3, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    MINJOON KIM, CHAEJIN LEE, SANG-YOUL YOON, SEONG-HYUN PARK, JEONG-HYUN HWANG, KYUNGHUN KANG, EUNHEE PARK, SUNHA CHOI, SHIN YUP LEE, SEUNG SOO YOO, YEE SOO CHAE, KI-SU PARK. COMPARATIVE ANALYSIS OF THE LUMBOPERITONEAL SHUNT VERSUS VENTRICULOPERITONEAL SHUNT FOR LEPT OMENINGEAL METASTASIS-ASSOCIATED HYDROCEPHALUS IN NON-SMALL CELL LUNG CANCER. ACTA NEUROCHIRURGICA 167 (2025). DOI: 10.1007/S00701-025-06490-Y ABSTRACT PURPOSE: LEPTOMENINGEAL METASTASIS (LM)-ASSOCIATED HYDROCEPHALUS IS A RARE BUT SEVERE COMPLICATION OF NON-SMALL CELL LUNG CANCER (NSCLC). THE SPREAD OF MALIGNANT CELLS TO THE LEPTOMENINGES OBSTRUCTS CEREBROSPINAL FLUID FLOW AND INCREASES INTRACRANIAL PRESSURE (ICP). THIS STUDY COMPARED THE OUTCOMES OF LUMBOPERITONEAL (LP) AND VENTRICULOPERITONEAL (VP) SHUNT SURGERIES IN MANAGING LM-ASSOCIATED HYDROCEPHALUS, FOCUSING ON SYMPTOM-FREE PERIODS (SFPS) AND OVERALL SURVIVAL (OS). METHODS: A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON 43 NSCLC PATIENTS WITH LM-ASSOCIATED HYDROCEPHALUS WHO UNDERWENT SHUNT SURGERY BETWEEN 2017 AND 2024. PATIENTS WERE CLASSIFIED INTO LP (N = 23) AND VP (N = 20) GROUPS. CLINICAL CHARACTERISTICS, SURGICAL OUTCOMES, AND SURVIVAL RATES WERE ANALYZED USING KAPLAN¿MEIER SURVIVAL AND COX REGRESSION ANALYSES. KARNOFSKY PERFORMANCE STATUS (KPS), INCREASED INTRACRANIAL PRESSURE (IICP) SYMPTOMS, AND POSTOPERATIVE EPIDERMAL GROWTH FACTOR RECEPTOR-TYROSINE KINASE INHIBITOR (EGFR-TKI) TREATMENT WERE EVALUATED FOR PROGNOSTIC SIGNIFICANCE. RESULTS: NO SIGNIFICANT DIFFERENCE WAS OBSERVED BETWEEN VP AND LP SHUNT SURGERIES REGARDING SFP (VP: 5.02 ± 1.29 MONTHS, LP: 7.50 ± 2.86 MONTHS, P = 0.906) OR OS (VP: 8.43 ± 1.89 MONTHS, LP: 9.62 ± 3.20 MONTHS, P = 0.820). HIGH PREOPERATIVE KPS, ABSENCE OF ICP SYMPTOMS, AND POSTOPERATIVE EGFR-TKI TREATMENT WERE SIGNIFICANTLY ASSOCIATED WITH IMPROVED SFP AND OS (P < 0.05). LP SHUNT SURGERY HAD SHORTER ANESTHESIA AND FEWER COMPLICATIONS COMPARED TO VP SHUNT SURGERY, REPRESENTING A VIABLE OPTION FOR PATIENTS UNSUITABLE FOR GENERAL ANESTHESIA. CONCLUSION: LP AND VP SHUNT SURGERIES ARE EQUALLY EFFECTIVE FOR PATIENTS WITH LM-ASSOCIATED HYDROCEPHALUS IN NSCLC. LP SHUNT SURGERY UNDER LOCAL ANESTHESIA COULD BE RECOMMENDED FOR ITS SAFETY AND PATIENT ACCEPTABILITY. FAVORABLE PROGNOSTIC FACTORS, INCLUDING HIGH KPS, ABSENCE OF ICP, AND POSTOPERATIVE EGFR-TKI TREATMENT, SHOULD GUIDE INDIVIDUALIZED TREATMENT STRATEGIES TO ENHANCE PATIENT OUTCOMES AND QUALITY OF LIFE. REPORTED EVENTS: - POST-OPERATIVE COMPLICATIONS INCLUDED CATHETER DISLODGEMENT IN 1 PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458704 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown