BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA NSC LUMBOPERITONEAL SHUNT KIT

    MDR report key: 6983700 · Received October 27, 2017

    Report

    Report Number
    2021898-2017-00549
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    September 26, 2017
    Report Date
    December 1, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169010796
    PMA / PMN Number
    K091312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT AND MET THE REQUIREMENTS FOR LEAK TESTING. THE VALVE WAS RETURNED AT PL 1.5 AND WAS NOT ADJUSTABLE; THEREFORE REFLUX, PRESSURE-FLOW AND PRE-IMPLANTATION TESTING ARE PRECLUDED. THERE WAS PROTEINACEOUS DEBRIS NOTED WITHIN THE INTERIOR AND EXTERIOR OF THE VALVE. DEBRIS WITHIN THE VALVE MAY INTERFERE WITH THE ADJUSTMENT MECHANISM RESULTING IN DIFFICULTY ADJUSTING 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¿. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS CLOGGED. THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763503 STRATA NSC LUMBOPERITONEAL SHUNT KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 44420 E26768 00643169010796

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R