BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 884773 · Received July 24, 2007

    Report

    Report Number
    2182207-2007-02288
    Event Type
    Injury
    Date Received
    July 24, 2007
    Report Date
    January 10, 2007
    Manufacturer
    NEUROLOGICAL DIV, MEDTRONIC, INC.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (SEE ADDITIONAL SCANNED PAGES).

    Description of Event or Problem · 1

    MCMILLAN, MD, ET AL. "CATHETER-ASSOCIATED MASSES IN PATIENT'S RECEIVING INTRATHECAL ANALGESIC THERAPY." INTL ANESTHESIA RESEARCH SOCIETY. 2003; 96:186-90. A PATIENT WITH FAILED BACK SURGERY SYNDROME EXPERIENCED SYMPTOMS OF NEURITIC PAIN AND PARALYSIS OF THE LEFT LEG. AN INTRATHECAL MASS WAS DIAGNOSED. THE PATIENT REQUIRED EMERGENCY SURGERY DECOMPRESSION LAMINECTOMY FOR SPINAL CORD COMPRESSION AND SUFFERED PERMANENT FUNCTIONAL LEFT LOWER EXTREMITY PARESIS. CULTURES OF THE PUMP CONTENTS AND PATHOLOGY SPECIMENS WERE STERILE. TREATMENT TIME WAS 25 MONTHS. MEDICATION MORPHINE 75 MG/ML AT A DAILY DOSE OF 16 MG, DILUENT 0.25% BUPIVICAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK NEUROLOGICAL DIV, MEDTRONIC, INC. CATHETER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability EXPLANTED| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT#UNK