BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 860699 · Received June 4, 2007

    Report

    Report Number
    6000030-2007-01905
    Event Type
    Other
    Date Received
    June 4, 2007
    Report Date
    May 8, 2007
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004/S54
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ARTICLE LISTS INFO SUGGESTING A PT BEING TREATED FOR SPASTICITY WITH AN IMPLANTABLE INFUSION PUMP (ITB) EXPERIENCED LUMBAR SWELLING AND THE FORMATION ON AN ENCAPSULATED CYST ENCLOSING THE CATHETER CONNECTOR. THE PT LACKED ENERGY, FAINTED SEVERAL TIMES, EXPERIENCED HEADACHE AND NAUSEA. DESPITE EXTENSIVE TESTING, THE CAUSE OF THE CYST COULD NOT BE DETERMINED. FLOW TESTING DID CONFIRM THE INTEGRITY OF THE PUMP AND CATHETER. NO ACTION WAS TAKEN TO REMOVE THE SYSTEM. THE PT WAS MONITORED AND, ONE YEAR LATER, THE CYST WAS STILL PRESENT BUT THE PATIENT'S OVERALL CONDITION HAD IMPROVED. NO ADDITIONAL INFO CONCERNING EVENT RESOLUTION AND PT OUTCOME WAS PROVIDED. JOURNAL REFERENCE: HOVING, MD, ET AL. "THE USE OF AN INDIUM DTPA FLOW STUDY IN THE EVALUATION OF A LUMBAR SWELLING IN A GIRL WITH A BACLOFEN PUMP." NEUROPEDIATRICS, 2006; 37: 99-101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRATHECAL CATHETER LKK RICE CREEK MANUFACTURING 8731 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other IMPLANTABLE INFUSION PUMP