BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE/SHUNT

    MDR report key: 23280360 · Received October 15, 2025

    Report

    Report Number
    9612501-2025-02635
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 13, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    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

    XI LIU, FAN ZHANG, XING LV, YIBO YIN, MENGYU GAO, HONG SHE, LI LIU. TREATMENT OF PYOGENIC VENTRICULITIS WITH RETROAURICULAR EXTERNAL VENTRICULAR DRAINAGE. WORLD NEUROSURGERY 202 (2025). DOI: 10.1016/J.WNEU.2025.124349. BACKGROUND: PYOGENIC VENTRICULITIS (PV) AND INTRAVENTRICULAR EMPYEMA (IVE) ARE SEVERE INTRACRANIAL INFECTIONS WITH HIGH MORBIDITY AND MORTALITY RATES. CURRENTLY, THERE IS NO STANDARDIZED TREATMENT STRATEGY FOR THESE CONDITIONS. EXISTING THERAPEUTIC APPROACHES, INCLUDING NEUROENDOSCOPIC LAVAGE, REPEATED EXTERNAL VENTRICULAR DRAINAGE (EVD), AND LONG-TUNNELED EVD, EACH HAVE THEIR RESPECTIVE LIMITATIONS. BUILDING ON THE THEORIES OF LONG-TUNNELED EVD, WE DEVELOPED THE RETROAURICULAR EXTERNAL VENTRICULAR DRAINAGE (RAEVD) TECHNIQUE. THIS STUDY AIMS TO ASSESS THE CLINICAL EFFECTIVENESS AND SAFETY OF RAEVD IN PATIENTS WITH PV AND IVE. METHODS: RAEVD WAS PERFORMED UNDER LOCAL ANESTHESIA USING A STANDARD 10-FR (3.3 MM) EVD CATHETER, WITH THE DISTAL EXIT POSITIONED IN THE NON-HAIR-BEARING RETROAURICULAR REGION. THIS RETROSPECTIVE SINGLE-CENTER STUDY INCLUDED 7 PATIENTS (9 RAEVD PROCEDURES). CLINICAL OUTCOMES, DRAINAGE DURATION, COMPLICATIONS, AND OUTCOMES, AS MEASURED BY THE MODIFIED RANKIN SCALE (MRS), WERE ANALYZED. RESULTS: THE MEDIAN DRAINAGE DURATION WAS 23 DAYS (INTERQUARTILE RANGE [IQR]: 14¿30 DAYS). NO CATHETER-RELATED INFECTIONS, CEREBROSPINAL FLUID LEAKAGE, OR DISLODGMENT OCCURRED. THE MEDIAN MRS SCORE IMPROVED FROM 4 (IQR, 4¿5) PREOPERATIVELY TO 1 (IQR, 0¿6) POSTOPERATIVELY. FIVE PATIENTS RECEIVED VENTRICULOPERITONEAL SHUNTS. FOUR PATIENTS (57.1%) ACHIEVED FAVORABLE OUTCOMES (MRS 0¿1). TWO PATIENTS DIED (MORTALITY RATE: 28.6%). CONCLUSIONS: RAEVD APPEARS TO BE A SAFE AND EFFECTIVE TECHNIQUE FOR MANAGING PV AND IVE, WITH POTENTIAL ADVANTAGES IN PROLONGED DRAINAGE DURATION, CATHETER PATENCY, AND PROCEDURAL SIMPLICITY. FUTURE STUDIES WITH LARGER COHORTS AND LONGER FOLLOW-UP PERIODS ARE NEEDED TO FURTHER VALIDATE ITS EFFECTIVENESS. REPORTED EVENTS: - A 43-YEAR-OLD WOMAN PRESENTED WITH A 2-MONTH HISTORY OF PROGRESSIVE HEADACHE, LETHARGY, AND VISUAL DECLINE. SHE HAD PREVIOUSLY UNDERGONE VPS (MEDTRONIC, USA) FOR HYDROCEPHALUS 25 YEARS EARLIER, WITH A REVISION PERFORMED 8 YEARS AGO DUE TO CATHETER OBSTRUCTION. CRANIAL CT REVEALED NEAR-COMPLETE COLLAPSE OF THE BILATERAL VENTRICLES, WHILE AN EARLIER CT PERFORMED AT SYMPTOM ONSET SHOWED MILD VENTRICULAR ENLARGEMENT. LUMBAR PUNCTURE REVEALED A CSF PRESSURE OF 175 MMH2O, WITH NORMAL CYTOLOGICAL AND BIOCHEMICAL PARAMETERS. PRESSURE MEASUREMENT VIA THE SHUNT RESERVOIR INDICATED AN INTRALUMINAL PRESSURE OF 90 MMH2O, CONFIRMING SLIT VENTRICLE SYNDROME. TO ALLEVIATE SYMPTOMS, DAILY DRAINAGE OF 150 ML OF CSF WAS PERFORMED VIA THE SHUNT RESERVOIR FOR 2 DAYS. THE PATIENT SUBSEQUENTLY UNDERWENT ETV. PREOPERATIVE VENTRICULAR DILATION WAS ACHIEVED BY INJECTING 30 ML OF SALINE INTO THE SHUNT RESERVOIR. INTRAOPERATIVE NEUROENDOSCOPY REVEALED SEVERELY NARROWED VENTRICLES; ADDITIONAL SALINE WAS INFUSED TO FACILITATE ENDOSCOPIC ACCESS, ALLOWING FOR SUCCESSFUL COMPLETION OF THE ETV. ETV SUCCESS WAS CONFIRMED BY DIRECT VISUALIZATION OF THE BASILAR ARTERY BRANCHES THROUGH THE NEWLY CREATED STOMA. A RAEVD WAS INSERTED ON THE LEFT SIDE FOR CONTINUOUS CSF DRAINAGE. THE PATIENT EXPERIENCED SIGNIFICANT IMPROVEMENT IN HEADACHE AND VISUAL SYMPTOMS. HOWEVER, ON POSTOPERATIVE DAY 7, AN ELEVATED CSF WBC COUNT OF 1585 × 10 6 CELLS/L PROMPTED DRAIN REMOVAL. THE WBC COUNT RESOLVED FOLLOWING INTERMITTENT LUMBAR PUNCTURES. BY POSTOPERATIVE DAY 24, CT SHOWED NO VENTRICULAR DILATION, AND THE PATIENT WAS DISCHARGED WITHOUT RECURRENCE OF SYMPTOMS. AT THE 25-MONTH FOLLOW-UP, SHE REMAINED ASYMPTOMATIC, WITH AN MRS SCORE OF 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177956 UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention