BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 5130052 · Received October 25, 2004

    Report

    Report Number
    5130052
    Event Type
    Malfunction
    Date Received
    October 25, 2004
    Date of Event
    November 25, 2003
    Report Date
    October 11, 2004
    Manufacturer
    MEDTRONIC INC. USA
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BROKEN INTRATHECAL CATHETER ON DRUG ADMINISTRATION SYSTEM. THE INTRATHECAL PORTION OF THE CATHETER HAD MIGRATED COMPLETELY INTO THE INTRATHECAL SPACE AND WAS NOT RETRIEVABLE. THE NEW CATHETER WAS PLACED AT THE T10 LEVEL UNDER FLUOROSCOPIC CONTROL AND CONNECTED TO THE EXISTING EXTENSION CATHETER. MFR#: 6000030-2004-01420.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SYNCHRO MED 8617-18 LKK MEDTRONIC INC. USA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR