BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 23523191 · Received November 11, 2025

    Report

    Report Number
    9612501-2025-02956
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 11, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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

    TONG SUN, YI ZHANG, XIAOFENG CHEN, YIKAI YUAN, CHAO YOU, KE WU, JUNWEN GUAN. ELEVATED TNF- IN CEREBROSPINAL FLUID AS A POTENTIAL INFLAMMATORY MARKER IN POST-HEMORRHAGIC HYDROCEPHALUS: A PROSPECTIVE STUDY. NEUROSURGICAL REVIEW 48 (2025). DOI: 10.1007/S10143-025-03889-0 ABSTRACT POST-HEMORRHAGIC HYDROCEPHALUS (PHH) NECESSITATES SURGICAL INTERVENTION TO ALLEVIATE SYMPTOMS AND PREVENT NEUROLOGICAL SEQUELAE. THE ROLE OF INFLAMMATORY CYTOKINES IN PHH PATHOPHYSIOLOGY REMAINS UNCLEAR, PROMPTING THE NEED FOR A COMPREHENSIVE INVESTIGATION OF THEIR CEREBROSPINAL FLUID (CSF) PROFILE. THIS STUDY AIMED TO INVESTIGATE THE CHARACTERISTICS OF PATIENTS WITH PHH UNDERGOING SHUNT SURGERY AND EVALUATE CSF CYTOKINE LEVELS IN THESE PATIENTS. WE CONDUCTED A PROSPECTIVE, MULTI-CENTER TRIAL TO DETERMINE THE INFLAMMATORY CYTOKINE LEVELS AND EVALUATE SHUNT OUTCOMES IN PHH PATIENTS DURING THE PERIOD FROM DECEMBER 2019 TO JUNE 2021. UPON IDENTIFICATION OF CANDIDATES FOR SHUNT SURGERY, CSF SAMPLES WERE OBTAINED AND STORED FOR SUBSEQUENT ANALYSIS OF INFLAMMATORY CYTOKINES. OUTCOME MEASURES INCLUDED THE SYMPTOMATIC CONTROL RATE (SCR), SHUNT FAILURE RATE, EVANS INDEX, AND MODIFIED RANKIN SCALE (MRS) SCORE AT 6 MONTHS POSTOPERATIVELY. SCR ASSESSED VIA KIEFER HYDROCEPHALUS SCALE (KHS: GAIT, COGNITION, INCONTINENCE, HEADACHE, DIZZINESS). 24 PATIENTS WERE INCLUDED IN THE STUDY. CSF CYTOKINE LEVELS WERE COMPARED BETWEEN PHH PATIENTS AND TWO CONTROL GROUPS. THE RESULTS SHOWED ELEVATED CSF TUMOR NECROSIS FACTOR- (TNF-) LEVEL IN PHH PATIENTS COMPARED TO CONTROLS, INDICATING POTENTIAL INFLAMMATORY RESPONSE IN THESE PATIENTS. HOWEVER, NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN OTHER CYTOKINES, INCLUDING INTERLEUKIN-1 (IL-1), IL-1, IL-6, AND IL-10. FURTHERMORE, SHUNTING OUTCOMES WERE EVALUATED, DEMONSTRATING IMPROVEMENTS IN VENTRICULAR PARAMETERS AND NEUROFUNCTIONAL OUTCOMES POSTOPERATIVELY. ALTHOUGH SHUNT FAILURE OCCURRED IN 16.7% OF CASES, THE MAJORITY OF PATIENTS EXPERIENCED SATISFACTORY OUTCOMES WITH DECREASED MORBIDITY AND IMPROVED QUALITY OF LIFE. NO SEVERE ADVERSE EVENTS WERE REPORTED DURING THE 6-MONTH FOLLOW-UP PERIOD. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN CYTOKINE LEVELS BETWEEN THE SHUNT-SUCCESS AND SHUNT-FAILURE GROUPS FOR TNF-, IL-1, IL-1, IL-6, AND IL-10. THIS STUDY PROVIDES INSIGHTS INTO THE CLINICAL CHARACTERISTICS, INFLAMMATORY PROFILES, AND SHUNTING OUTCOMES OF PHH PATIENTS, HIGHLIGHTING THE POTENTIAL ROLE OF TNF- IN THE PATHOPHYSIOLOGY OF PHH. FURTHER RESEARCH IS WARRANTED TO ELUCIDATE THE UNDERLYING MECHANISMS AND OPTIMIZE TREATMENT STRATEGIES FOR THIS PATIENT POPULATION. REPORTED EVENTS - THE OUTCOMES OF SHUNT SURGERY INDICATED A SHUNT FAILURE RATE OF 16.7% (4 CASES). AMONG THESE, 2 PATIENTS (8.3%) REQUIRED SHUNT SYSTEM REPLACEMENT DUE TO SHUNT OBSTRUCTION, 1 PATIENT (4.2%) UNDERWENT SHUNT SYSTEM REMOVAL DUE TO SHUNT INFECTION, AND 1 PATIENT (4.2%) UNDERWENT REPEAT SHUNT SURGERY DUE TO INEFFECTIVE SHUNTING. REGARDING COMPLICATIONS, A TOTAL OF 5 TYPES OF COMPLICATIONS WERE OBSERVED IN THIS COHORT: OVERDRAINAGE, INADEQUATE DRAINAGE, ABDOMINAL DISCOMFORT, SHUNT INFECTION, AND SHUNT OBSTRUCTION. THE OVERALL INCIDENCE OF COMPLICATIONS WAS 25.0% (6 CASES); AMONG ALL COMPLICATIONS, THE INCIDENCE RATES OF OVERDRAINAGE, UNDERDRAINAGE, AND SHUNT OBSTRUCTION WERE 8.3% EACH, WHILE THAT OF SHUNT INFECTION AND ABDOMINAL DISCOMFORT WERE BOTH 4.2%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525182 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA 42866 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention