BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHUNTASSISTANT 20

    MDR report key: 8520783 · Received April 16, 2019

    Report

    Report Number
    3004721439-2019-00089
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    March 26, 2019
    Report Date
    April 29, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K110206
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 ASSOCIATED MEDWATCHES: 3004721439-2019-00088. MANUFACTURING SITE EVALUATION: VISUAL INSPECTION - NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVE WERE DETECTED DURING THE VISUAL INSPECTION. PERMEABILITY TEST- THE TEST INDICATED THAT THE VALVE HAS A BLOCKAGE. ADJUSTMENT TEST AND BRAKING FORCE/FUNCTION- THIS IS FIXED PRESSURE VALVE. THESE TESTS ARE NOT APPLICABLE. RESULTS - AFTER THE ABOVE TESTS, WE HAVE DISMANTLED THE VALVE. INSIDE THE VALVE WE HAVE FOUND MINIMAL BUILD-UP OF SUBSTANCES (LIKELY PROTEIN). BASED ON OUR INVESTIGATION, WE CAN CONFIRM THE PRESENCE OCCLUSION IN THE VALVE, LIKELY DUE TO DEPOSITS OBSERVED INSIDE. EVEN A SMALL AMOUNT OF NON-VISIBLE BLOOD OR PROTEIN CAN LEAD TO TEMPORARY BLOCKAGE AND COULD BE RESPONSIBLE FOR THE SUSPECTED MALFUNCTION IN THE PAST. AS DESCRIBED IN OUR LITERATURE, THE PROBLEM ENCOUNTERED IS ONE OF THE KNOWN, INEVITABLE RISKS OF HC-THERAPY BY SHUNT IMPLANTS. 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.

    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: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV VALVE WITH SHUNT ASSISTANT WAS BLOCKED. A PATIENT UNDERWENT A SHUNT IMPLANTATION PROCEDURE ON (B)(6) 2007. SOMETIME LATER POSTOPERATIVELY, IT WAS NOTED THAT THE VALVE WAS BLOCKED. THE VALVE AND SHUNT ASSISTANT WERE REPLACED ON (B)(6) 2019 DUE TO THIS MALFUNCTION. FURTHER DETAILS HAVE BEEN REQUESTED. THIS REPORT REFERS TO THE SHUNT ASSISTANT. ASSOCIATED MEDWATCHES: 3004721439-2019-00088.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311918 SHUNTASSISTANT 20 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FV251T 4502425997

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention