BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-FLOW CONTROL SHUNT KIT, CONT., SMALL, LOW PR

    MDR report key: 1032209 · Received April 21, 2008

    Report

    Report Number
    2021898-2008-00094
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 25, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K841442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT AND PASSED REFLUX TESTING. IT WAS WITHIN SPECS FOR ALL PRESSURE-FLOW AND PREIMPLANTATION TESTS. THE VALVE HAD TWO TEARS IN THE SIDES OF THE PROXIMAL OCCLUDER. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE VALVES CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR PRODS ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS LEAKING BEFORE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-FLOW CONTROL SHUNT KIT, CONT., SMALL, LOW PR 84JXG JXG MEDTRONIC NEUROSURGERY NA C08109

    Patients

    Seq Age Sex Outcome Treatment
    1