BEUDAMED
    FDA Adverse Event Summary report: N

    LIMITORR

    MDR report key: 2070427 · Received April 14, 2011

    Report

    Report Number
    2070427
    Date Received
    April 14, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 14, 2011
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LIMITORR IN PLACE AND SET TO DRAIN 20ML. STOPPER NOT EFFECTIVE. CEREBRAL SPINAL FLUID (CSF) CONTINUED TO DRAIN. AT TIMES DRAINAGE EXCEEDED 25ML. SYSTEM HAD TO BE MANUALLY CLAMPED TO PREVENT FLOW OF CSF. THE LOT OF PRODUCT WAS REMOVED FROM OUR FACILITY BY THE SALES REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMITORR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG INTEGRA NEUROSCIENCES PR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR