BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA® NSC VALVE, REGULAR

    MDR report key: 4269758 · Received November 21, 2014

    Report

    Report Number
    2021898-2014-00459
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 28, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K033850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS RETURNED AT PL=1.0. ALL PERFORMANCE LEVELS COULD BE SET WITH A SINGLE ATTEMPT, AND THE VALVE DID NOT SPONTANEOUSLY CHANGE LEVELS DURING THE COURSE OF ANALYSIS. THEREFORE THE CONDITIONS OF THIS COMPLAINT COULD NOT BE VERIFIED BY LABORATORY PERSONNEL. IT MET THE REQUIREMENTS FOR PATENCY, SIPHON, REFLUX, PRESSURE-FLOW, PRE-IMPLANTATION, AND LEAK TESTING. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING PREIMPLANTATION TESTING THE VALVE COULD NOT BE ADJUSTED FROM PRESSURE-LEVEL SETTING 1.0. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757717 STRATA® NSC VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D57516

    Patients

    Seq Age Sex Outcome Treatment
    1