BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA® NSC VALVE, REGULAR

    MDR report key: 4298882 · Received December 4, 2014

    Report

    Report Number
    2021898-2014-00482
    Event Type
    Injury
    Date Received
    December 4, 2014
    Date of Event
    November 7, 2014
    Report Date
    November 7, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K033850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS NOT PATENT. PROTEINACEOUS DEBRIS WAS OBSERVED IN THE INTERIOR OF THE VALVE. THE LEAKAGE, REFLUX, PRESSURE-FLOW, AND PREIMPLANTATION TESTS WERE PRECLUDED DUE TO THE VALVE OCCLUSION. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE STATES THAT THE VALVE 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS NOT PATENT. PROTEINACEOUS DEBRIS WAS OBSERVED IN THE INTERIOR OF THE VALVE. THE LEAKAGE, REFLUX, PRESSURE-FLOW, AND PREIMPLANTATION TESTS WERE PRECLUDED DUE TO THE VALVE OCCLUSION. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE STATES THAT THE VALVE MAY BECOME OCCLUDED INTERNALLY DUE TO TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION OR OTHER DEBRIS. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A STRATA VALVE THAT WAS IMPLANTED SOMETIME IN 2013 WAS EXPLANTED FROM THE PATIENT BECAUSE THE SURGEON SUSPECTED THAT IT WAS OCCLUDED. IT WAS ALSO REPORTED THAT THE PATIENT IS CURRENTLY DOING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783033 STRATA® NSC VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Hospitalization| R