BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC LP VALVE

    MDR report key: 3923797 · Received July 9, 2014

    Report

    Report Number
    2021898-2014-00236
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K091312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT THERE SHOULD BE A MAXIMUM OF 1 CM TISSUE THICKNESS OVER THE VALVE MECHANISM TO FACILITATE THE READING AND SETTING OF THE VALVE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF THE 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 THE VALVE WAS NOT RESPONDING TO POST-OPERATIVE PRESSURE CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401585 STRATA NSC LP VALVE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1