BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV W/SHUNTASSIST.25 + DIST.CATH.

    MDR report key: 18312027 · Received December 12, 2023

    Report

    Report Number
    3004721439-2023-00363
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 12, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906132187
    PMA / PMN Number
    K103003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: DURING THE INVESTIGATION, NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVES WAS DETERMINED. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT ALL COMPONENTS ARE PERMEABLE. COMPUTER CONTROLLED TEST: TO INVESTIGATE THE CLAIM OF UNDER-DRAINAGE, THE OPENING PRESSURE IS MEASURED USING A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS WHICH SIMULATES A CEREBROSPINAL FLUID FLOW. THE VALVES ARE TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE VALVES OPERATE WITHIN THE ACCEPTED TOLERANCE IN BOTH POSITIONS. ADJUSTMENT TEST: THE PROGAV WAS TESTED AND IS NOT ADJUSTABLE. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE BRAKE FUNCTION IS OPERATIONAL; HOWEVER, THE BRAKING FORCE CANNOT BE MEASURED DUE TO THE NON-ADJUSTABILITY OF THE VALVE. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVES, DEPOSITS WERE FOUND IN BOTH VALVES. TO MAKE THE PROTEINS / DEPOSITS IN THE SHUNT SYSTEM MORE VISIBLE, THEY WERE COLORED USING A STAINING SOLUTION. RESULTS: BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE ADJUSTMENT DIFFICULTIES IN THE PROGAV. THE DETERMINED DEPOSITS CAN BE NAMED AS THE CAUSE FOR THE FUNCTIONAL DEVIATION. PROTEINS IN THE CEREBROSPINAL FLUID CAN INFLUENCE THE FUNCTION TEMPORARILY AND ARE KNOWN SIDE EFFECTS IN HYDROCEPHALUS THERAPY. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE SHUNT SYSTEM MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG. NO FURTHER REGULATORY ACTIONS ARE REQUIRED FROM OUR POINT OF VIEW.

    Description of Event or Problem · 0

    IMPLANTATION: (B)(6) 2014 EXPLANTATION: (B)(6) 2023 FILE ENTERED WITH LIMITED INFORMATION. DELIVERED IN RETURNKIT IN UNKNOWN LIQUID. AGE Y: 12 / WEIGHT KG: 35 / HEIGHT CM: UNKNOWN / GENDER: FEMALE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112194 PROGAV W/SHUNTASSIST.25 + DIST.CATH. HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV421T 20021580 04041906132187

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Unknown Required Intervention