BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 24791618 · Received April 6, 2026

    Report

    Report Number
    9612501-2026-00997
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    March 14, 2026
    Report Date
    April 6, 2026
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Adverse Event
    Yes
    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: - IN OUR COHORT, 24.07% OF CHILDREN REQUIRED AT LEAST ONE REVISION (N = 13). THE OVERALL REVISION RATE WAS 6.36 PER 100 PERSON-YEARS (95% CI, 3.94¿9.73); HOWEVER, A TOTAL OF 21 REVISION PROCEDURES WERE PERFORMED. THE LEADING INDICATION FOR SHUNT REVISION WAS PROXIMAL CATHETER DYSFUNCTION (N = 9, 47.37%), FOLLOWED BY DISTAL CATHETER DYSFUNCTION (N = 5, 26.32%) AND VALVE MECHANISM MALFUNCTION (N = 2, 10.53%). IN TWO CASES, THE CAUSE OF SHUNT DYSFUNCTION COULD NOT BE UNEQUIVOCALLY DETERMINED. IN TWO PATIENTS IN WHOM ADEQUATE REGULATION OF CSF DRAINAGE COULD NOT BE ACHIEVED WITH A PROGRAMMABLE SHUNT ALONE, AN ANTISIPHON DEVICE WAS INCORPORATED INTO THE SHUNT SYSTEM; BOTH OF THESE CASES SUBSEQUENTLY REQUIRED REPLACEMENT OF EITHER THE VENTRICULAR OR DISTAL CATHETER. ONLY ONE CASE OF SHUNT INFECTION WAS NOTED (5.26%). SIX PATIENTS UNDERWENT TWO REVISIONS, AND ONE PATIENT REQUIRED THREE REVISIONS, ACCOUNTING FOR 15 OF THE 21 REVISION PROCEDURES (71.43%). SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849956 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention