BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA®

    MDR report key: 22179734 · Received June 10, 2025

    Report

    Report Number
    9612501-2025-01478
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 10, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    MAJD SAADALDEEN, ANNA JEPPSSON, PER HELLSTRÖM, KAJ BLENNOW, HENRIK ZETTERBERG, CARSTEN WIKKELSØ AND MATS TULLBERG. IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS: ASSOCIATIONS BETWEEN CSF BIOMARKERS, CLINICAL SYMPTOMS, AND OUTCOME AFTER SHUNT SURGERY. FLUIDS AND BARRIERS OF THE CNS 22 (2025). DOI: 10.1186/S12987-025-00661-W ABSTRACT BACKGROUND: THE NEUROCHEMICAL ALTERATIONS IN CEREBROSPINAL FLUID (CSF) ASSOCIATED WITH THE TYPICAL SYMPTOMATOLOGY IN IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH) AND THEIR ASSOCIATION WITH OUTCOME AFTER SHUNT SURGERY ARE UNSETTLED. AIM: TO EXPLORE ASSOCIATIONS BETWEEN CONCENTRATIONS OF CSF BIOMARKERS REFLECTING AMYLOID- AND TAU PATHOLOGY, NEURONAL DEGENERATION AS WELL AS ASTROCYTIC ACTIVATION AND THE CHARACTERISTIC SYMPTOMATOLOGY IN INPH AND TO EXAMINE WHETHER THESE BIOMARKERS CAN PREDICT THE POSTOPERATIVE OUTCOME IN ALL PATIENTS AND IN PATIENTS WITHOUT EVIDENCE OF ALZHEIMER¿S DISEASE (AD) PATHOLOGY. METHODS: THIS EXPLORATIVE STUDY INCLUDED 81 PATIENTS DIAGNOSED WITH INPH AT THE HYDROCEPHALUS RESEARCH UNIT, SAHLGRENSKA. SYMPTOMS WERE ASSESSED USING THE INPH-SCALE AND STANDARDIZED CLINICAL TESTS MEASURING GAIT, BALANCE, COGNITION AND URINARY INCONTINENCE BEFORE AND MEDIAN 8 MONTHS AFTER SHUNT SURGERY. PRE-OPERATIVE LUMBAR CSF CONCENTRATIONS OF A¿38, A¿40, A¿42, RATIO A¿42/A¿40, SAPP¿, SAPP¿, T-TAU, P-TAU, MCP-1, AND NFL WERE ANALYZED. A LOW A¿42/A¿40 RATIO DEFINED PATIENTS WITH AD PATHOLOGY. CORRELATION AND REGRESSION ANALYSES BETWEEN BIOMARKER CONCENTRATIONS AND CLINICAL SYMPTOMS AT BASELINE AS WELL AS POSTOPERATIVE CHANGE IN SYMPTOMS AFTER SURGERY, WERE PERFORMED. RESULTS: HIGHER NFL CORRELATED WITH MORE PRONOUNCED IMPAIRMENT IN ALL CLINICAL TESTS, I.E.INCLUDED MEASURES OF GAIT, BALANCE, COGNITION AND URINARY INCONTINENCE (RP=0.25¿0.46, P <(><<)> 0.05). HIGHER T-TAU AND P-TAU CORRELATED WITH POORER PERFORMANCE IN COGNITIVE TESTS (RP=0.26¿0.39, P <(><<)> 0.05). NO BIOMARKER COULD DIFFERENTIATE BETWEEN IMPROVED AND UNIMPROVED PATIENTS IN THE WHOLE SAMPLE OR IN AD-PATHOLOGY NEGATIVE PATIENTS. LOW RATIO A¿42/A¿40 LACKED PREDICTIVE VALUE. A HIGHER PREOPERATIVE P-TAU WAS WEAKLY CORRELATED WITH LESS PRONOUNCED OVERALL CLINICAL IMPROVEMENT (RP = -0.238, P = 0.036). CONCLUSIONS: AXONAL DEGENERATION, AS INDICATED BY ELEVATED NFL, IS PROBABLY INVOLVED IN THE GENERATION OF THE FULL INPH TETRADE OF SYMPTOMS AND TAU PATHOLOGY MORE SPECIFICALLY WITH INPH COGNITIVE IMPAIRMENT. NO CSF BIOMARKER COULD IDENTIFY SHUNT RESPONDERS. CSF EVIDENCE OF ALZHEIMER PATHOLOGY SHOULD NOT BE USED TO EXCLUDE PATIENTS FROM SHUNT SURGERY. REPORTED EVENT: - 41% WERE NOT IMPROVED BY AT LEAST 5 POINTS ON THE INPH SCALE. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806829 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC DOMINICANA UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown