BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC LUMBOPERITONEAL SHUNT KIT

    MDR report key: 6914116 · Received October 4, 2017

    Report

    Report Number
    2021898-2017-00499
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    September 1, 2017
    Report Date
    November 14, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K091312
    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 LEAK TESTING. HOWEVER, THE DEVICE DID NOT MEET THE REQUIREMENTS FOR REFLUX, PRESSURE-FLOW, AND PRE-IMPLANTATION TESTING. THERE WAS PROTEINACEOUS DEBRIS NOTED IN THE INTERIOR AND EXTERIOR OF THE DEVICE. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN AFFECTING THE FLOW OF FLUID THROUGH THE VALVE AND MAY RESULT IN FLUID REFLUX. 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.¿ APPROXIMATELY 51.5 CM OF THE PERITONEAL CATHETER WAS RETURNED. THE RETURNED CATHETER WAS PATENT AND MET THE REQUIREMENTS FOR LEAK TESTING. APPROXIMATELY 53.5 CM OF THE VENTRICULAR CATHETER WAS RETURNED. THE RETURNED CATHETER WAS PATENT AND MET THE REQUIREMENTS FOR LEAK TESTING. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO FLOW THROUGH THE VALVE DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE¿S ¿REBOUND¿ WAS NOT GOOD PRIOR TO IMPLANT TESTING. WHEN THE SURGEON IMPLANTED THE VALVE, IT WAS FOUND THAT IT WAS ¿NOT WORKING.¿ THE VALVE WAS REPLACED AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692876 STRATA NSC LUMBOPERITONEAL SHUNT KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 44420 E22647

    Patients

    Seq Age Sex Outcome Treatment
    1