BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTSDAMPROGAV 2.0 SYS SA2.0 25 & CONTROL RES.

    MDR report key: 16553432 · Received March 16, 2023

    Report

    Report Number
    3004721439-2023-00055
    Event Type
    Injury
    Date Received
    March 16, 2023
    Date of Event
    February 9, 2023
    Report Date
    March 16, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906503178
    PMA / PMN Number
    K190174
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: NO SIGNIFICANT DEFORMATION OR DAMAGE TO THE VALVES WAS FOUND DURING THE INSPECTION, BUT DEPOSITS WERE FOUND INSIDE THE SUPPLIED CONTROL RESERVOIR. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT THE VALVE IS 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 VALVE IS TESTED IN THE HORIZONTAL POSITION. THE RESULTS SHOW THAT THE VALVE IS NOT OPERATING WITHIN THE ACCEPTABLE TOLERANCE IN THE HORIZONTAL POSITION. ADJUSTMENT TEST: THE PROGAV 2.0 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 VALVE, DEPOSITS WERE FOUND INSIDE. TO MAKE THE PROTEINS / DEPOSITS IN THE VALVE MORE VISIBLE, THEY WERE COLORED USING A STAINING SOLUTION. RESULT: IN ADVANCE, WE WOULD LIKE TO POINT OUT THAT THE PRODUCT SENT IN WAS NOT SUBMERGED IN LIQUID AT THE TIME OF DELIVERY. THE TESTING OF DRY VALVES IS ONLY OF LIMITED VALUE. THE PRODUCT PROPERTIES CAN BE INFLUENCED BY DRY RESIDUES OF CEREBROSPINAL FLUID OR BLOOD. DESPITE THIS, WE HAVE EXAMINED THE VALVE. BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE A SLOWER OUTFLOW IN THE VALVE. THE DETERMINED DEPOSITS CAN BE NAMED AS THE CAUSE FOR THE SLOWER OUTFLOW. 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 VALVE 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

    IT WAS REPORTED THAT A PROGAV 2.0 (PART # FX552T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 60 YEARS. WEIGHT: 86 KILOGRAMS (KG). HEIGHT: 172 CENTIMETERS (CM). GENDER: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077664 OTSDAMPROGAV 2.0 SYS SA2.0 25 & CONTROL RES. HYDROCHEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX552T 20042872 04041906503178

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention