BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2 VALVE, REGULAR

    MDR report key: 2241078 · Received August 17, 2011

    Report

    Report Number
    2021898-2011-00192
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND WERE UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PT DEVELOPED LOWER LIMB WEAKNESS AFTER DEVICE IMPLANTATION. ACCORDING TO THE REPORT, IT WAS THOUGHT THAT THE DEVICE WAS UNDERDRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2 VALVE, REGULAR JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C79568

    Patients

    Seq Age Sex Outcome Treatment
    1