BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 2111703 · Received May 25, 2011

    Report

    Report Number
    2021898-2011-00092
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 12, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 AND REFLUX TESTING. THIS PRECLUDED PRESSURE-FLOW AND PREIMPLANTATION TESTING. PROTEINACEOUS DEBRIS WAS FOUND ON THE EXTERIOR AND INTERIOR OF THE VALVE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT "SHUNT OBSTRUCTION MAY OCCUR IN ANY OF THE COMPONENTS OF THE SHUNT SYSTEM. THE SYSTEM MAY BECOME OCCLUDED INTERNALLY DUE TO TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION OR OTHER DEBRIS." A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. NO IMPACT TO PT REPORTED. 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 A REVISION OF THE DEVICE OCCURRED. ACCORDING TO THE REPORT, IT WAS BELIEVED THAT THE VALVE WAS BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY C73177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R