BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-FLOW CONTROL AVALVE, CONTOURED SMALL, HIGH PRESSURE

    MDR report key: 3070591 · Received April 17, 2013

    Report

    Report Number
    2021898-2013-00142
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K841442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT AND MET THE REQUIREMENTS FOR REFLUX TESTING. HOWEVER, IT DID NOT MEET THE SPECIFICATIONS FOR LEAK, PRESSURE-FLOW, AND PREIMPLANTATION TESTING DUE TO TWO TEARS IN THE SILICONE NEAR THE PROXIMAL EDGE OF THE RESERVOIR AS WELL AS THE PRESENCE OF CRYSTALLINE DEBRIS WITHIN THE VALVE. IT IS UNK HOW OR WHEN THE TEARS OCCURRED, BUT THE CRYSTALLINE DEBRIS IS LIKELY THE RESULT OF DISSOLVED PARTICLES IN THE WATER USED FOR PREIMPLANTATION TESTING THAT CRYSTALIZED INSIDE THE DEVICE AFTER BEING AUTOCLAVED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. ALSO, CRYSTALLINE DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN, RESULTING IN FLUID REFLUX AND/OR SIPHONING. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PRODUCT CATALOG INDICATED THAT THE DEVICE, A HIGH PRESSURE VALVE, SHOULD BE OPERATING AT A PRESSURE RANGE BETWEEN 135 - 155 MM H2O, BUT THAT THE PHYSICIAN FOUND IT TO BE OPERATING AT ABOUT 70 MM H2O. NO ADVERSE IMPACT OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166526 CSF-FLOW CONTROL AVALVE, CONTOURED SMALL, HIGH PRESSURE JXG - SHUNT, CENTRAL, NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D04968

    Patients

    Seq Age Sex Outcome Treatment
    1