BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 6045978 · Received October 20, 2016

    Report

    Report Number
    2021898-2016-00381
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 20, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT. THEREFORE THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. THE VALVE MET THE REQUIREMENTS FOR SIPHON, PREIMPLANTATION AND LEAK TESTING. HOWEVER, THE VALVE DID NOT MEET REQUIREMENTS FOR REFLUX AND PRESSURE-FLOW TESTING. PROTEINACEOUS DEBRIS WAS OBSERVED IN THE INTERIOR AND EXTERIOR OF THE VALVE. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN RESULTING IN FLUID REFLUX AND AFFECTING THE FLOW OF FLUID THROUGH 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.¿ 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 FOUND TO BE OBSTRUCTED. ACCORDING TO THE REPORT, THE PRESSURE LEVEL WAS SET TO 0.5 AT IMPLANTATION, BUT THE PATIENT'S INTRACRANIAL PRESSURE REMAINED HIGH AND THE DEVICE WAS EXPLANTED. IT WAS REPORTED THE DOCTOR REPLACED THE DEVICE WITH ANOTHER DEVICE. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695374 STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D73049

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R