BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAV SHUNTSYSTEM

    MDR report key: 7779147 · Received August 13, 2018

    Report

    Report Number
    3004721439-2018-00169
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Report Date
    September 16, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K103003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVE WAS RECEIVED SUBMERGED IN A STERILE SALTWATER SOLUTION IN A PLASTIC CONTAINER. A VISUAL INSPECTION WAS PERFORMED AND THERE WERE SCRATCHES AND BLOODY RESIDUE IN THE OUTER CASING OF THE VALVE. THE PROGAV VALVE HOUSING WAS MEASURED TO CONFIRM THE PRESENCE OF A DEFORMATION. THE HOUSING DEFORMATION MEASURED AT 0.046 MM, OUTSIDE THE TOLERANCE OF 0 +/- 0.02MM. A PERMEABILITY TEST SHOWED THAT THE VALVE WAS PERMEABLE. THE VALVE WAS TESTED AND WAS ADJUSTED TO ALL SPECIFIED PRESSURES. THE BRAKE FUNCTIONALITY TEST SHOWED THAT THE BRAKE FUNCTION WAS FULLY OPERATIONAL AND THE BRAKING FORCE WAS WITHIN THE GIVEN TOLERANCES. TO TEST THE OPENING PRESSURE, WE USED A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS WHICH SIMULATES A CEREBROSPINAL FLUID FLOW. THE VALVE OPERATED WITHIN THE ACCEPTED TOLERANCE. BASED ON INVESTIGATION RESULTS, UNDERDRAINAGE COULD NOT BE CONFIRMED. NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DATE OF EVENT: UNKNOWN. PENDING FURTHER INFORMATION.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE THAT "THERE WAS UNDER-DRAINAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620326 PROGAV SHUNTSYSTEM HYDROCEPHALUS SHUNT JXG CHRISTOPH MIETHKE GMBH & CO. KG FV434T 20008062

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention