BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0®

    MDR report key: 21732593 · Received March 31, 2025

    Report

    Report Number
    2916714-2025-00011
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 2, 2025
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906137298
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: VISUAL INSPECTION: DURING THE INVESTIGATION, NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVE WERE DETERMINED. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT ALL COMPONENTS ARE PERMEABLE. COMPUTER CONTROLLED TEST: TO INVESTIGATE, 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 VALVE OPERATES WITHIN THE PERMISSIBLE TOLERANCE IN ITS RESPECTIVE RELEVANT POSITIONS. 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 WÄHLEN SIE EIN ELEMENT AUS. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVE, NO DEPOSITS WERE FOUND IN. RESULTS: BASED ON OUR INVESTIGATION RESULTS, WE CANNOT DETERMINE FUNCTIONAL DEVIATIONS OR OTHER ABNORMALITIES IN THE PRODUCT. HOW THE ABOVEMENTIONED FUNCTIONAL IMPAIRMENT OCCURRED IS NOT CLEAR TO US AT THE TIME OF EXAMINATION. 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

    INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR (PART# FX431T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE SHUNT WAS NOT WORKING PROPERLY. REPORTEDLY THE PATIENT UNDERWENT A REVISION ON (B)(6) 2025. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR (PART# FX431T) WAS IMPLANTED ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THE SHUNT WAS NOT WORKING PROPERLY. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833758 PROGAV 2.0® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG CHRISTOPH MIETHKE GMBH & CO KG FX431T 20070464 04041906137298

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Required Intervention