BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC VALVE, REGULAR

    MDR report key: 6395023 · Received March 10, 2017

    Report

    Report Number
    2021898-2017-00105
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 8, 2017
    Report Date
    February 10, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169466111
    PMA / PMN Number
    K033850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT. IT MET THE REQUIREMENTS FOR REFLUX, PRESSURE-FLOW, PRE-IMPLANTATION. PROTEINACEOUS DEBRIS WAS NOTED WITHIN THE INTERIOR AND EXTERIOR 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¿. THE VALVE DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A TEAR IN THE TOP OF THE CASSETTE HOUSING CHAMBER. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. 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. 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 RESERVOIR LEAKED DURING PRE-IMPLANTATION TESTING. ACCORDING TO THE REPORT, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178668 STRATA NSC VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY E18938 00643169466111

    Patients

    Seq Age Sex Outcome Treatment
    1