BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM

    MDR report key: 7536870 · Received May 22, 2018

    Report

    Report Number
    MW5077406
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    April 20, 2018
    Report Date
    May 11, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A EVD CONNECTED TO INTEGRA LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM. CAREGIVERS CRNS, PAS) NOTICED CRACKS IN TRANSDUCER MOUNT STOPCOCK. TUBING AND DRAINAGE SYSTEM REPLACED X 3 TIMES BUT PT ACQUIRED VENTRICULITIS. DIAGNOSIS OR REASON FOR USE: HYDROCEPHALUS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378267 LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM JXG INTEGRA LIFESCIENCES CORP.
    378268 LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM JXG INTEGRA LIFESCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O