BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV SYS W/SA 20 A.CONTROL RESERVOIR

    MDR report key: 17691159 · Received September 6, 2023

    Report

    Report Number
    3004721439-2023-00259
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    August 8, 2023
    Report Date
    October 10, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906130862
    PMA / PMN Number
    K103003
    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

    INVESTIGATION: VISUAL INSPECTION: DURING THE INVESTIGATION, A SLIGHTLY DEFORMATIONS OF THE VALVE WAS DETECTED DURING THE VISUAL INSPECTION, THE MEASUREMENT OF THE PLANE PARALLELISM HAS CONFIRMED THIS WITH A VALUE OF -0.045 MM - OUTSIDE THE TOLERANCE OF 0 ± 0.02 MM. 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 OPERATED WITHIN THE ACCEPTED TOLERANCE IN BOTH POSITIONS. ADJUSTMENT TEST: THE PROGAV WAS TESTED AND IS ADJUSTABLE TO ALL SPECIFIED PRESSURES. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE BRAKE FUNCTION IS FULLY OPERATIONAL AND THE BRAKING FORCE IS WITHIN THE GIVEN TOLERANCES. 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 DEPOSITS AND A DEFORMATION OF THE OUTER HOUSING. THE DETERMINED DEPOSITS AND DEFORMATION EFFECT NOT THE FUNCTIONALITY OF THE VALVES. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOUD RELEVANT ADDITIONAL INFORNATION/INVESTIGATION RESULTS BECAME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PATIENT INFORMATION: AGE: 61 YEARS. HEIGHT: 168 CENTIMETERS. WEIGHT: 120 KILOGRAMS. GENDER: MALE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FX434-T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED A BLOCKAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON UNKNOWN. THE COMPLAINANT DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: UNKNOWN . WEIGHT: UNKNOWN . HEIGHT: UNKNOWN. GENDER: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831675 PROGAV SYS W/SA 20 A.CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV434-T 20054489 04041906130862

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention