BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1081332 · Received July 24, 2008

    Report

    Report Number
    2182207-2008-04354
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    December 31, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER MFR WAS NOT IDENTIFIED. THE REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: VADERA ET AL. "INTRATHECAL GRANULOMA AND INTRAMEDULLARY ABSCESS ASSOCIATED WITH AN INTRATHECAL MORPHINE PUMP", INTERNATIONAL NEUROMODULATION SOCIETY 2007;10;1;P 6-10. "THE ARTICLE DESCRIBES A STUDY INVOLVING A MALE PT WITH WAS ADMITTED WITH A 3 WEEK HISTORY OF THE INABILITY TO AMBULATE OR MOVE HIS LEGS. HE WAS BEING TREATED WITH AN INTRATHECAL DRUG DELIVERY SYSTEM FOR BACK PAIN ASSOCIATED WITH MULTIPLE FAILED BACK SURGERIES. EXAMINATION REVEALED NO MOVEMENT IN HIS LOWER EXTREMITIES. MRI SHOWED AN INTRATHECAL MASS AT THE CATHETER TIP (SPINAL LEVEL T10 AND T11). CONTRAST-ENHANCING IMAGING ALSO INDICATED AN INTRAMEDULLARY ABSCESS AT T11 AND T12. PATIENT UNDERWENT LAMINECTOMIES WITH COMPLETE RESECTION OF THE INFLAMMATORY MASS, CATHETER TIP AND PUMP. MYELOTOMY WAS ALSO DONE TO ASPIRATE THE ABSCESS. THE INFLAMMATORY MASS CONTAINED INFLAMMATORY MARKERS AND NECROTIC TISSUE. THE ABSCESS AND PUMP RESERVOIR CONTAINED STREPTOCOCCUS ANGINOSUS. THE CAUSE OF THE INFECTION COULD NOT BE DETERMINED. PRIOR TO PRESENTATION, THE PT HAD BEEN RECEIVING 32 MG/DAY OF INTRATHECAL MORPHINE VIA A HIGHLY CONCENTRATED 50 MG/ML SOLUTION. PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND HAD AN UNEVENTFUL RECOVERY. AT 20 MONTHS, THE PT WAS CLASSIFIED AS A D ON THE ASIA IMPAIRMENT SCALE; MOTOR FUNCTION WAS PRESERVED ON THE LEFT SIDE BELOW THE T11 ABSCESS LEVEL AND HALF OF HIS KEY MUSCLES HAD MUSCLE GRADE OF 3 OR MORE. THE PT HAD ALTERED SENSATION OF HIS LEFT LEG. PATIENT CURRENTLY WALKS WITH AN ASSISTIVE DEVICE. MRI SCANS DEMONSTRATE NO REMAINING ABSCESS. PAIN IS CONTROLLED BY ORAL NARCOTIC MEDICATIONS."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| S PROGRAMMER AND IMPLANTABLE DRUG PUMP| (PROGRAMMABLE)