BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAEDI-SHUNTASSTISTANT 10

    MDR report key: 8520782 · Received April 16, 2019

    Report

    Report Number
    3004721439-2019-00090
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    March 25, 2019
    Report Date
    May 14, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K011030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 SECTION A - PATIENT DATA: PATIENT HEIGHT 128.4 CM D6 & 7: IMPLANT AND EXPLANT DATE ASSOCIATED MEDWATCHES: 3004721439-2019-00091 . MANUFACTURING SITE EVALUATION: VISUAL INSPECTION - NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVE AND THE RESERVOIR WERE DETECTED DURING THE VISUAL EXAMINATION. PERMEABILITY TEST- A TEST HAS SHOWN THAT BOTH THE SHUNT ASSISTANT VALVE AND CATHETER AR PERMEABLE. ADJUSTMENT TEST- THIS IS A FIXED PRESSURE VALVE. AN ADJUST TEST IS NOT APPLICABLE. BRAKING FORCE/FUNCTION TEST- THIS IS A FIXED PRESSURE VALVE. A BRAKING FORCE AND BRAKE FUNCTION TEST IS NOT APPLICABLE. COMPUTER CONTROLLED TEST - THE TEST IS PERFORMED WITH MIETHKE COMPUTER-CONTROLLED TESTED APPARATUS TO MEASURE OPENING PRESSURE. THE VALVE WAS TESTED BY SIMULATING A CEREBROSPINAL FLUID (CSF) FLOW. THE VALVE IS TESTED IN A VERTICAL POSITION. THE RESULTS SHOW THAT THE VALVE OPERATES WITHIN THE ACCEPTED TOLERANCE. RESULTS - AFTER THE ABOVE TESTS, WE HAVE DISMANTLED THE VALVE. INSIDE THE VALVE WE HAVE FOUND BUILD-UP OF SUBSTANCES (LIKELY PROTEIN). BASED ON OUR INVESTIGATION, WE ARE UNABLE TO SUBSTANTIATE THE CLAIM OF OVER-DRAINAGE OF THE VALVE AT THE TIME OF THE EXAMINATION. THE VALVE OPERATES WITHIN THE SPECIFIED TOLERANCES. HOWEVER, IT IS POSSIBLE THAT THE DEPOSITS OBSERVED INSIDE THE VALVE, EVEN THOUGH MINIMAL IN NATURE, COULD HAVE CAUSED THE MALFUNCTION IN THE PAST. AS DESCRIBED IN OUR LITERATURE, THE PROBLEM ENCOUNTERED IS ONE OF THE KNOWN, INEVITABLE RISKS OF HYDROCEPHALUS THERAPY WITH 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. D6: IMPLANT DATE UNKNOWN. 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 OVER-DRAINING. A PATIENT UNDERWENT A SHUNT IMPLANTATION PROCEDURE IN (B)(6) 2018. DUE TO AN EXCESSIVE AMOUNT OF CEREBROSPINAL FLUID (CSF) DRAINAGE, THE VALVE WAS ADJUSTED STEP-BY-STEP UP TO 20CM H2O. ALTHOUGH IT HAD BEEN ADJUSTED TO THE MAXIMUM OPENING PRESSURE, THE DRAINAGE VOLUME DID NOT DECREASE; THE PRESSURE HAD BEEN CONFIRMED VIA DIAGNOSTIC TOOLS. THE VALVE AND SHUNT ASSISTANT WERE REPLACED ON (B)(6) 2019 DUE TO THIS MALFUNCTION. PATIENT DATA WAS NOT PROVIDED. FURTHER DETAILS HAVE BEEN REQUESTED. THIS REPORT REFERS TO THE SHUNT ASSISTANT. ASSOCIATED MEDWATCHES: 3004721439-2019-00091.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311916 PAEDI-SHUNTASSTISTANT 10 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FV288T 20037460

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention