BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1562499 · Received December 2, 2009

    Report

    Report Number
    3007566237-2009-08898
    Event Type
    Injury
    Date Received
    December 2, 2009
    Date of Event
    September 14, 2009
    Report Date
    November 25, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1146-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO DETERMINE.

    Description of Event or Problem · 1

    LITERATURE: ABEJON D, SAZ, J.M., LEY L, SANCHEZ M.R., DEL POZO, C. [SPINAL GRANULOMA IN A PT RECEIVING A SPINAL INFUSION OF MORPHINE AND CLONIDINE]. REV ESP ANESTESIOL REANIM. 2009; 56(6):380-4. SUMMARY: THIS ARTICLE PRESENTS A CLINICAL CASE OF A PT WHO DEVELOPED A CATHETER-TIP GRANULOMA THAT REQUIRED EMERGENCY SURGERY FOR RESOLUTIONS AFTER YRS OF INTRATHECAL TREATMENT. REPORTABLE EVENT: THE PT UNDERWENT A SUCCESSFUL TRIAL (> 80% PAIN RELIEF) WITH MORPHINE AND CLONIDINE AND WAS IMPLANTED WITH AN INTRATHECAL INFUSION SYSTEM. THE PT BEGAN TO LOSE EFFICACY AFTER THE FIRST YEAR OF TREATMENT REQUIRING COMBINATIONS OF DIFFERENT DRUGS IN THE SECOND YEAR INCLUDING CLONIDINE ALONE, CLONIDINE AND BUPIVACAINE, PETHIDINE ALONE, BACLOFEN ALONE, AND BACLOFEN AND MORPHINE WITH A SIGNIFICANT THERAPEUTIC RESPONSE (> 50%). DURING THE THIRD YEAR OF TREATMENT, THE DOSE OF MORPHINE AND CLONIDINE WAS PROGRESSIVELY INCREASED FROM THE INITIAL DOSES OF 3-6 MG/DAY MORPHINE AND 250-275 MCG/DAY CLONIDINE TO A MAXIMUM DOSE OF 34 MG/DAY MORPHINE AND 1271 MCG/DAY CLONIDINE WITHOUT THE DESIRED RESULTS. DURING THIS TWO-YEAR INTERVAL A ROUTINE FOLLOW-UP MRI OF THE SPINAL COLUMN REPORTED THE PRESENCE OF SPINAL CORD ALTERATIONS AT T2-T3 CONSISTING OF HEMORRHAGIC REMAINS RELATED TO THE PREVIOUSLY EXCISED CAVERNOUS ANGIOMA WITHOUT OTHER CHANGES WHEN COMPARED TO PREVIOUS MRI. AFTER SUCCESSIVE REVISION OF THE INTRATHECAL TREATMENT, SIX YRS AFTER IMPLANT, THE PT DEVELOPED PROGRESSIVE NEUROPATHIC PAIN SYMPTOMS IN THE UPPER LIMBS WITH ANOMALOUS NEUROLOGICAL EXAM. AN MRI WAS ENLARGED IN THE CERVICO-DORSAL AREA AND SHOWED THE PRESENCE OF AN INTRADURAL-EXTRAMEDULLARY LESION WITH A LARGE BASE OF IMPLANTATION IN THE POSTERIOR SPINAL DURA MATER AT THE T1-T2 LEVEL. THE LESION IMPINGED POSTERIORLY, DEFORMING THE SPINAL CORD WITHOUT ALTERING THE INTRAMEDULLARY SIGNAL DESTINY IN THE T2 SAGITTAL SEQUENCE, SUGGESTIVE OF MENINGIOMA. THE PT WAS REFERRED TO NEUROSURGERY. A DORSAL LAMINECTOMY CENTERING ON T2 WAS PERFORMED AND THE EXTRAMEDULLARY TUMOR THAT SURROUNDED THE TIP OF THE INTRATHECAL CATHETER HAD A MACROSCOPIC APPEARANCE CONSISTENT WITH GRANULOMA WAS EXCISED ALONG WITH TIP OF THE CATHETER. THE REST OF THE CATHETER WAS LEFT IMPLANTED. INTRAOPERATIVE HISTOPATHOLOGICAL STUDY SHOWED SPINDLE-CELL PROLIFERATION, HYPOCELLULARITY AND NO ATYPIA, WHICH WAS COMPATIBLE WITH GRANULOMATOUS GROWTH AROUND THE CATHETER TIP. A SUBSEQUENT HISTOPATHOLOGICAL STUDY REVEALED THE PRESENCE OF A DORSAL EPIDURAL MASS CONSISTING OF FRAGMENTS OF MUSCULOADIPOSE TISSUE THAT ENGULFED SMALL BONE FRAGMENTS, WITH EXTENSIVE FIBROSIS, AND WITH REACTIVE AND INFLAMMATORY CHANGES, BUT WITHOUT ANY MORPHOLOGICAL FINDINGS INDICATING MALIGNANCY. FOLLOWING SURGERY, THE DOSE OF INTRATHECAL DRUGS REMAINED STABLE AT 34 MG/DAY MORPHINE AND 1001.38 MCG/DAY CLONIDINE. THE PT PERSISTED IN UNDERLYING PAIN SYMPTOMS AND WAS IMPLANTED WITH A DEEP BRAIN STIMULATION SYSTEM. THE RESULTED IN A REDUCTION IN THE INTENSITY OF BASELINE PAIN WHICH LED TO PROGRESSIVE REDUCTION IN THE INTRATHECAL DRUGS DOSES TO 9 MG/DAY MORPHINE AND 265.40 MCG/DAY CLINIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK MEDTRONIC NEUROMODULATION 8627 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention PROGRAMMER: MODEL UNK, LOT# UNK| EXPLANTED:| CATHETER: MODEL 8709, LOT# UNK| IMPLANTED: