BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA 2, ADJUSTABLE VALVE, REGULAR

    MDR report key: 1892228 · Received October 26, 2010

    Report

    Report Number
    2021898-2010-00267
    Event Type
    Injury
    Date Received
    October 26, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED VALVE WAS PATENT AND PASSED SIPHON TESTING. HOWEVER, IT DID NOT PASS LEAK TESTING DUE TO PIN HOLES IN THE SILICONE DOME ABOVE THE RESERVOIR. IT ALSO DID NOT MEET THE REQUIREMENTS FOR REFLUX TESTING AND WAS OUT OF SPECIFICATIONS FOR PRESSURE-FLOW TESTING AT PERFORMANCE LEVEL 1.0, 46.8 ML/HR @ 0 CM HYDROSTATIC PRESSURE. ALL OTHER PRESSURE-FLOW AND PREIMPLANTATION PRESSURE RESULTS WERE WITHIN SPECIFICATIONS. A DISSECTION OF THE DEVICE FOUND FIBROUS DEBRIS WITHIN THE VALVE MECHANISM. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE WARN THAT "THE SYSTEM MAY BECOME OCCLUDED INTERNALLY DUE TO TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION OR OTHER DEBRIS." SUCH DEBRIS CAN AFFECT THE VALVE MECHANISM, RESULTING IN REFLUX OR HIGH PRESSURE-FLOW RESULTS. 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 THAT THE SURGEON REMOVED/EXPLANTED THE SHUNT DUE TO PATIENT DISCOMFORT AND REPLACED WITH A NEW SHUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2, ADJUSTABLE VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R