BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBDURAL CATHETER KIT COMPLETE

    MDR report key: 1100763 · Received March 20, 2008

    Report

    Report Number
    9612007-2008-00010
    Event Type
    Malfunction
    Date Received
    March 20, 2008
    Date of Event
    October 13, 2007
    Report Date
    March 20, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED FOR RETURN. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED BY MEDWATCH THE FOLLOWING: "A SUBDURAL DRAIN PLACED BY THE SURGEON FOR THE PT'S ACUTE AND CHRONIC SUBDURAL HEMATOMA. THE SUBDURAL DRAIN WAS NOT DRAINING, SO A SECOND SURGEON, WHO WAS TAKING CALLS FOR ALL NEUROSURGERY CASES, ATTEMPTED TO PULL THE DRAIN. WHEN THE DRAIN WAS PULLED, IT REMAINED STUCK UNTIL THE END/TIP OF THE CATHETER DISLODGED AND WAS LEFT IN THE CRANIAL CAVITY. THE PT'S CONDITION WARRANTED A SECONDARY CRANIOTOMY, REMOVAL OF THE TIP, AND REPLACEMENT OF THE SUBDURAL DRAIN." "DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE?". "NO". "WHAT WAS THE ORIGINAL INTENDED PROCEDURE?". "LEFT FRONTAL CRANIOTOMY, EVACUATION OF SUBDURAL HEMATOMA." "DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING.)"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBDURAL CATHETER KIT COMPLETE * JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * 0144719

    Patients

    Seq Age Sex Outcome Treatment
    1 *