BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_PUMP

    MDR report key: 3528494 · Received December 19, 2013

    Report

    Report Number
    3007566237-2013-04098
    Event Type
    Injury
    Date Received
    December 19, 2013
    Date of Event
    July 10, 2013
    Report Date
    November 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4). WAS NOT POSSIBLE TO MATCH THIS EVENT TO A PREVIOUSLY REPORTED EVENT. ACTUAL EVENT DATE WAS UNKNOWN. THIS DATE IS BASED ON THE DATE OF PUBLICATION.

    Description of Event or Problem · 1

    FREMONDIERE, F., SAOUT, V., FERRAPIE, A. L., LACOEUILLE, F., COUTURIER, O., MENEI, P., RICHARD, I., DINOMAIS, M. ANNALS OF PHYSICAL AND REHABILITATION MEDICINE. ISOTOPIC SCINTIGRAPHY COUPLED TO TOMODENSITOMETRY: INTEREST IN THE DIAGNOSIS OF BACLOFEN PUMP DYSFUNCT ION. 2013. 56. SUMMARY/REPORTED EVENT: THIS REPORT REFERS TO (B)(6) FEMALE PATIENT. MEDICAL HISTORY INCLUDED MULTIPLE SCLEROSIS AND NO CONCOMITANT MEDICATION WAS REPORTED. PATIENT RECEIVED INTRATHECAL BACLOFEN (ITB, (UNKNOWN MANUFACTURER) FOR THE TREATMENT OF SPASTIC PARAPLEGIA FROM AN UNKNOWN DATE. DESPITE OF GRADUAL INCREASE OF (ITB) TO 850 (XG/ DAY), SPASTICITY REMAINED UNCONTROLLED. ON AN UNKNOWN DATE, TESTS WITH BACLOFEN INFUSION BY LUMBAR PUNCTURE (150 (XG) REFUTED ANY RESISTANCE TO THIS DRUG. PLAIN FILMS FOUND A DISTAL CATHETER DIRECTED DOWNWARD WITH A CATHETER TIP AT L5 LEVEL WITHOUT APPARENT DISCONNECTION OR FAILURE. AN INDIUM 111 DTPA SCINTIGRAPHY COUPLED WITH A TOMODENSITOMETRY WAS PERFORMED. IT WAS FOUND THAT THE ACTIVITY OF THE RADIOISOTOPE WAS MAXIMAL NEXT TO THE FIRST SACRAL VERTEBRA RELATED WITH THE ATYPICAL ORIENTATION OF THE INTRATHECAL CATHETER DISTAL EXTREMITY. NO LEAKAGE OF THE PRODUCT WAS REVEALED. VERY LOW ACTIVITY OF THE RADIOISOTOPE WAS OBSERVED ABOVE THE LUMBAR LEVEL. THE CATHETER WAS THEN REPLACED AT T7 LEVEL. ONE MONTH LATER, SPASTICITY WAS WELL CONTROLLED. SIX MONTHS LATER, A SECOND INDIUM111 DTPA SCINTIGRAPHY CONFIRMED A HIGH ACTIVITY OF INTRATHECAL RADIOISOTOPE UP TO THE BASAL CISTERNS. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED. THE SERIOUSNESS OF THE EVENT WAS NOT RE PORTED. THE AUTHOR CONCLUDED THAT THIS OBSERVATION EMPHASIZES THE IMPORTANCE OF INDIUM111 DTPA SCINTIGRAPHY COUPLED WITH A TOMODENSITOMETRY IN THE ETIOLOGIC DIAGNOSIS OF UNCONTROLLED SPASTICITY IN PATIENTS WITH ITB PUMP. BACLOFEN STAGNATION IN THE DURAL SAC SHOWN IN THESE INVESTIGATIONS WAS RELATED WITH THE ORIENTATION OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664325 UNKNOWN_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention