BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSA VALVE

    MDR report key: 3883082 · Received February 19, 2014

    Report

    Report Number
    2916714-2014-00101
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Report Date
    February 18, 2014
    Manufacturer
    CHRISTOPH MEITHKE GMBH & CO
    Product Code
    JXG
    PMA / PMN Number
    K120559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(6) 2014. MANUFACTURING SITE EVALUATION: ALL PARAMETERS OF THE VALVE WERE INSPECTED AND PASSED PRIOR TO ITS RELEASE. THE INVESTIGATIONS OF THE VALVE RESULTED IN THE FAILURE OF THE CONTROL FUNCTION. THE BODY OF THE VALVE IS DEFORMED. THIS DEFORMATION CAUSES THE LOWERING OF THE HOUSING MEMBRANE, RESULTING IN FAILURE OF BRAKE FUNCTION. DAMAGE TO THE VALVE IS OF UNKNOWN ORIGIN, HOWEVER, THIS TYPE OF DAMAGE IS GENERALLY RELATED TO EXCESSIVE PRESSURE WHILE USING ADJUSTMENT TOOL.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). VALVE HAS BEEN IMPLANTED IN (B)(6) 2013. IT WAS ADJUSTABLE AND READABLE UNTIL (B)(6) 2013. NOW IT IS NOT READABLE ANYMORE AND THE DOCTOR JUST GOT THE INFO "UNUSED RANGE". THE VALVE HAD TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103848 PROSA VALVE JXG CHRISTOPH MEITHKE GMBH & CO FV701T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other