BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2853276 · Received November 30, 2012

    Report

    Report Number
    3007566237-2012-02881
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    April 16, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPORTED EVENT. (B)(4). IT WAS NOT CLEAR WHETHER THE PATIENT HAD A 20ML OR 40ML PUMP. EITHER Z-1150-2008 OR Z-1151-2008 WOULD APPLY.

    Description of Event or Problem · 1

    WALLACE, M., YAKSH, T. L. CHARACTERISTICS OF DISTRIBUTION OF MORPHINE AND METABOLITES IN CEREBROSPINAL FLUID AND PLASMA WITH CHRONIC INTRATHECAL MORPHINE INFUSION IN HUMANS. ANESTHESIA AND ANALGESIA. 2012;115(4):797-804. DOI; 10.1213/ANE.0B013E3182645DFD. SUMMARY: DESPITE WIDESPREAD USE OF CHRONIC INTRATHECAL (IT) INFUSIONS OF MORPHINE, THERE IS LITTLE SYSTEMATIC HUMAN WORK EVALUATING THE STEADY STATE MORPHINE CONCENTRATIONS OR CEREBROSPINAL (CSF) CHEMISTRY AFTER LONG-TERM IT MORPHINE DELIVERY. WE SOUGHT TO ADDRESS THESE ISSUES IN PATIENTS RECEIVING CHRONIC IT MORPHINE INFUSION. PAIN PATIENTS WITH IMPLANTED CATHETERS AND PUMPS (RANGE: 127 TO 2165 DAYS), RECEIVING A STABLE DOSING (_1 WEEK) OF IT MORPHINE BY INFUSION, WERE ENTERED INTO THE STUDY. THE FOLLOWING SEQUENCE WAS PERFORMED: ESTIMATION OF PAIN SCORE; RADIOGRAPH LOCALIZATION OF CATHETER TIP; PERCUTANEOUS SAMPLING OF LUMBAR CSF AT THE L4 TO 5 OR L5-S1 SPACE. CSF/PLASMA SAMPLES WERE ASSAYED FOR CHEMISTRY, AND MORPHINE AND ITS 3/6 GLUCURONIDE METABOLITES (M3G, M6G) BY LIQUID CHROMATOGRAPHY MASS SPECTROMETRY. NINETEEN PATIENTS WERE ENROLLED. CSF SAMPLES WERE OBTAINED FROM 16 SUBJECTS. THREE PATIENTS WERE NOT INCLUDED IN THE PRIMARY ANALYSIS BECAUSE 1 CATHETER WAS EPIDURAL, 1 CATHETER WAS FRACTURED, AND 1 HAD A GRANULOMA AT THE CATHETER TIP. OF THE 13 SAMPLED PATIENTS, THE RANGE OF DAILY DOSES, RATES, AND CONCENTRATIONS WERE 1.6 TO 25 MG/D AND 0.1 TO 1 ML/D, 5 TO 50 MG/ML, RESPECTIVELY. THE PRINCIPAL OBSERVATIONS WERE AS FOLLOWS: (I) MORPHINE, M3G, AND M6G WERE PRESENT IN THE CSF AND PLASMA AND SHOWED A SIGNIFICANT REGRESSION SLOPE WHEN PLOTTED VERSUS DAILY DOSE; (II) IN CONTRAST, THE REGRESSION SLOPE OF THE GROUP RATIO MORPHINE:M3G:M6G PLOTTED VERSUS DAILY DOSE IN CSF OR PLASMA WAS NOT DIFFERENT FROM ZERO; (III) PLOTTING "NORMALIZED" CSF ANALYTE CONCENTRATION (E.G., CONCENTRATION AT SITE/DAILY IT MORPHINE DOSE) AGAINST THE SEGMENTAL DISTANCE OF THE SAMPLING SITE FROM THE CATHETER TIP REVEALED A SIGNIFICANT DECLINE IN CONCENTRATION OF MORPHINE, BUT NOT OF CONJUGATES AS A FUNCTION OF DISTANCE FROM THE CATHETER TIP; (IV) PLOTTING CSF PROTEIN, GLUCOSE, AND RED AND WHITE CELL COUNTS VERSUS DAILY MORPHINE DOSE OR MORPHINE CONCENTRATION AT THE SAMPLING SITE REVEALED NO SIGNIFICANT REGRESSION; AND (V) PATIENTS WITH A CATHETER FAILURE OR A GRANULOMA SHOWED REDUCED CONCENTRATIONS OF MORPHINE IN THEIR CSF. CHRONIC INFUSION OF MORPHINE SHOWS HIGH CONCENTRATIONS, WHICH CORRELATE WITH THE INFUSION DOSE AND THE PROXIMITY OF THE SAMPLING SITE TO THE INFUSION SITE WITH NO EFFECTS ON CSF CHEMISTRY. REPORTED EVENT: PATIENT 6 DEVELOPED A GRANULOMA AT THE CATHETER TIP WHICH WAS REVEALED BY MRI. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE CATHETER WAS REMOVED AND A NEW CATHETER PLACED. THE PROCEDURE WAS UNEVENTFUL. THE GRANULOMA RESOLVED AND THE PATIENT CONTINUED TO RECEIVE GOOD PAIN CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention