BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 2160781 · Received July 7, 2011

    Report

    Report Number
    2021898-2011-00140
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT AND PASSED LEAK TESTING. THE DEVICE DID NOT MEET THE REQUIREMENTS FOR SIPHON OR REFLUX TESTING. THE VALVE MET ALL SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. ALL PERFORMANCE LEVELS COULD BE SET WITH A SINGLE ATTEMPT, AND A LEVEL CHANGE COULD NOT BE INDUCED BY LABORATORY PERSONNEL WITHOUT USING A MAGNET. A DISSECTION OF THE VALVE IDENTIFIED PROTEINACEOUS DEBRIS INSIDE THE VALVE ADJUSTMENT MECHANISM. STRATA PRODUCTS ARE DESIGNED TO BE ADJUSTED BY A STRONG MAGNET. INADVERTENT ADJUSTMENTS BY EXTERNAL MAGNETS ARE A KNOWN COMPLICATION WITH ADJUSTABLE VALVES. A REVIEW OF THE MANUFACTURING 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 STRATA VALVE WAS SET AT 2.5 AND TWICE SLIPPED BACK DOWN TO 0.5. THE SURGEON PERFORMED A REVISION SURGERY AND REPLACED IT WITH A NEW VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II VALVE, REGULAR JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C29767

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R