BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 1021619 · Received March 26, 2008

    Report

    Report Number
    2182207-2008-01583
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Report Date
    April 18, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    LITERATURE: ROCHE, N., ET AL. "MANAGEMENT OF INCREASE IN SPASTICITY IN PTS WITH INTRATHECAL BACLOFEN PUMPS." ANNALES DE READAPTION ET DE MEDICINE PHYSIQUE 2007; 50:93-99. CATHETER MIGRATION OF THE END OF THE CATHETER INTO THE SUBDURAL SPACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRATHECAL CATHETER LKK MEDTRONIC NEUROMODULATION CATHETER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention EXPLANTED| EXPLANTED| IMPLANTED| IMPLANTABLE INFUSION PUMP LOT #UNK| PROGRAMMER MODEL PROGRAMMER LOT #UNK| IMPLANTED