BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAV 2.0 WITH PED.PRECHAMBER

    MDR report key: 8409716 · Received March 11, 2019

    Report

    Report Number
    3004721439-2019-00066
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    February 6, 2019
    Report Date
    June 14, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: THE VALVE WAS MANUFACTURED BY A QUALIFIED EMPLOYEE; DEVIATIONS DURING ASSEMBLY DID NOT OCCUR. ALL PARAMETERS HAVE BEEN INSPECTED AND APPROVED DURING THE MANUFACTURING PROCESS. ALL PARAMETERS HAVE BEEN ASSESSED AS MEETING SPECIFICATIONS. INVESTIGATION - THE VALVE WAS RECEIVED IN THE ORIGINAL PACKAGING; IT WAS IN THE UNOPENED STERILE BAG. NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVE WERE DETECTED DURING THE VISUAL INSPECTION. LIGHT MARKINGS WERE OBSERVED ON THE STERILE BAG. PERMEABILITY TEST- THIS TEST WAS NOT PERFORMED AS THE DEVICE WAS STILL ENCLOSED.. ADJUSTMENT TEST - THIS HAS SHOWN THAT THE VALVE WAS ADJUSTABLE TO ALL SPECIFIED PRESSURES. BRAKING FORCE AND BRAKE FUNCTION TEST - THIS TEST WAS NOT PERFORMED AS THE DEVICE WAS STILL ENCLOSED IN THE STERILE BAG. RESULTS - BASED ON OUR INVESTIGATIONS, WE ARE UNABLE TO SUBSTANTIATE THE CLAIM OF NON-ADJUSTABILITY. THE VALVE WAS ADJUSTABLE TO ALL SETTINGS AS SPECIFIED. 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED: THE REPORTER CLARIFIED THAT THIS WAS AN INITIAL PROCEDURE AND THAT SHUNT WAS NEVER IMPLANTED. THE SURGEON COULD NOT GET IT TO PROGRAM PRIOR TO IMPLANTATION SO THEY OPENED AND IMPLANTED ANOTHER PROGAV.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV VALVE HAD AN ISSUE WITH PROGRAMMING. A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2019 DUE TO PROGAV VALVE WOULD NOT PROGRAM. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200583 PROGAV 2.0 WITH PED.PRECHAMBER HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FX466T 20038690

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention