BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAMR VALVE, REGULAR

    MDR report key: 6126428 · Received November 23, 2016

    Report

    Report Number
    2021898-2016-00438
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169692701
    PMA / PMN Number
    K152700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS NOT PATENT DUE TO A LARGE TEAR NOTED IN THE SIDE OF THE CASSETTE HOUSING CHAMBER. THEREFORE ALL FURTHER TESTING WAS PRECLUDED. 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.¿ IT IS ALSO SUGGESTED THAT THE VALVE BE PLACED IN A SURGICALLY CREATED LOOSE SUBGALEAL POCKET. THIS ALLOWS GENTLE PLACEMENT OF THE VALVE AND MINIMIZES HANDLING WITH SURGICAL TOOLS. PROTEINACEOUS DEBRIS WAS OBSERVED WITHIN THE INTERIOR AND EXTERIOR OF THE VALVE. THE INSTRUCTIONS FOR USE (IFU) 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. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS RIPPED INTRAOPERATIVELY. ACCORDING TO THE REPORT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775531 STRATAMR VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY E12950 00643169692701

    Patients

    Seq Age Sex Outcome Treatment
    1