BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA®

    MDR report key: 24791637 · Received April 6, 2026

    Report

    Report Number
    9612501-2026-00998
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 14, 2026
    Report Date
    April 6, 2026
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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

    RYSZARD SORDYL, NATALIA WYROBA, NATALIA KARDAS, MAREK MANDERA. THE APPLICATION OF PROGRAMMABLE SHUNTS IN THE MANAGEMENT OF HYDROCEPHALUS IN PEDIATRIC PATIENTS. CHILD¿S NERVOUS SYSTEM 42 (2026). DOI: 10.1007/S00381-026-07210-2 ABSTRACT PURPOSE: THIS STUDY AIMS TO ANALYZE THE USE OF PROGRAMMABLE SHUNTS IN THE TREATMENT OF HYDROCEPHALUS IN PEDIATRIC PATIENTS, WITH PARTICULAR EMPHASIS ON INDICATIONS AND TREATMENT OUTCOMES. METHODS: A RETROSPECTIVE ANALYSIS WAS CONDUCTED OF PEDIATRIC PATIENTS WHO UNDERWENT IMPLANTATION OF MEDTRONIC¿ STRATA II PROGRAMMABLE SHUNTS FOR HYDROCEPHALUS BETWEEN 2013 AND 2023. PATIENTS WITH TUMOR-RELATED HYDROCEPHALUS WERE EXCLUDED. RESULTS: THE STUDY POPULATION COMPRISED 54 PATIENTS (22 GIRLS AND 32 BOYS) WITH A MEDIAN AGE AT PROGRAMMABLE SHUNT IMPLANTATION OF 3.3 YEARS (RANGE 0.2¿17.4 YEARS) AND A MEAN FOLLOW-UP OF 6.2 YEARS (SD ± 2.9 YEARS). ADJUSTABLE VALVES WERE IMPLANTED DE NOVO IN 22 PATIENTS (40.74%) AND SECONDARILY IN 32 (59.26%). DE NOVO IMPLANTATION WAS PRIMARILY INDICATED FOR A SIGNIFICANTLY ENLARGED VENTRICULAR SYSTEM (N = 17, 77.27%), WHILE SECONDARY IMPLANTATION WAS MAINLY PERFORMED FOR OVERDRAINAGE SYNDROME (N = 15, 46.88%). REPROGRAMMING OF OPENING-PRESSURE SETTINGS WAS REQUIRED IN 44.44% OF CHILDREN (N = 24). SHUNT REVISIONS WERE PERFORMED IN 24.07% OF CASES (N = 13), WITH ALL MULTIPLE REVISIONS OBSERVED EXCLUSIVELY IN PATIENTS WITH POSTHEMORRHAGIC HYDROCEPHALUS (N = 7). AT 10 YEARS AFTER SHUNT IMPLANTATION, 90.9% OF PATIENTS IN THE DE NOVO GROUP REMAINED FREE FROM REVISION, COMPARED WITH 59.9% IN THE SECONDARY GROUP (LOG-RANK TEST, P = 0.023). CONCLUSIONS: THE ANALYSIS SUBSTANTIATED THAT PROGRAMMABLE SHUNT IMPLANTATION IS AN EFFECTIVE TREATMENT FOR PEDIATRIC HYDROCEPHALUS. IN MOST CASES, INITIAL VALVE SETTINGS WERE SUFFICIENT WITHOUT THE NEED FOR SUBSEQUENT ADJUSTMENTS. SECONDARY IMPLANTATION OF A SHUNT AND POSTHEMORRHAGIC HYDROCEPHALUS ETIOLOGY WERE ASSOCIATED WITH A HIGHER RISK OF REVISION. REPORTED EVENTS: - A CHANGE IN THE INITIAL OPENING PRESSURE SETTINGS WAS REQUIRED IN 44.44% OF PATIENTS (N = 24). ONLY THERAPEUTIC ADJUSTMENTS BASED ON THE PATIENT¿S CLINICAL AND/OR RADIOLOGICAL INDICATIONS WERE INCLUDED. AMONG THE 12 INFANT PATIENTS, UNPLANNED REPROGRAMMING WAS NECESSARY IN FIVE CASES (FOUR WITH A SINGLE ADJUSTMENT AND ONE WITH THREE ADJUSTMENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850178 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown