BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3858162 · Received June 10, 2014

    Report

    Report Number
    3007566237-2014-01580
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    June 7, 2012
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DATE REFLECTS THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    STETKAROVA, I., VRBA, I., TOMAS, R., KOFLER, M. DOES A NARROW SPINAL CANAL FACILITATE INTRATHECAL GRANULOMA FORMATION? A CASE REPORT. CESKÁ A SLOVENSKÁ NEUROLOGIE A NEUROCHIRURGIE. 2013; 76(1):110-112. SUMMARY: WE REPORT A CASE OF EARLY FORMATION OF A CATHETER TIP GRANULOMA IN A PATIENT WITH MULTILEVEL DEGENERATIVE SPINAL STENOSIS WHO DEVELOPED A GRANULOMA IN SPITE OF THE FACT THAT MORPHINE DOSAGE WAS AT LOWER RATE AND ADMINISTERED FOR A SHORT PERIOD OF TIME ONLY. METHODS: A (B)(6) WOMAN WITH A HISTORY OF CHRONIC LOW BACK PAIN DUE TO THE FAILED BACK SURGERY SYNDROME WAS TREATED EFFECTIVELY WITH 5MG/DAY MORPHINE VIA AN INTRATHECAL DRUG DELIVERY SYSTEM (IDDS). EIGHT MONTHS AFTER IDDS REPLACEMENT DUE TO END-OF-BATTERY-LIFE, THE PATIENT EXPERIENCED NEW SEVERE PAIN RADIATING DIFFUSELY TO THE LEFT LEG AND ACCOMPANIED BY SLIGHT WEAKNESS. RESULTS: MRI DISCLOSED MULTILEVEL DEGENERATIVE SPONDYLOGENIC STENOSIS AND AN INTRADURAL EXTRAMEDULLAR MASS AT THE T11 LEVEL WITH SPINAL CORD COMPRESSION. THE PATIENT UNDERWENT DECOMPRESSIVE HEMILAMINECTOMY AND REMOVAL OF ADHERENT FIBROTIC TISSUE ATTACHED TO THE SPINAL CORD AND TO THE TIP OF THE INTRATHECAL CATHETER. CONCLUSIONS: IN THIS PATIENT, A NARROW SPINAL CANAL, WHICH MAY HAVE CREATED UNFAVORABLE CONDITIONS FOR PROPER CSF CIRCULATION, MAY HAVE FACILITATED MORPHINE-ASSOCIATED GRANULOMA FORMATION DESPITE A SHORT-TERM LOW DOSE TREATMENT. REPORTED EVENT: A (B)(6) WOMEN WITH A HISTORY OF CHRONIC LOW BACK PAIN UNDERWENT A PUMP REPLACEMENT. THE PATIENT DID WELL WITH A DOSE OF MORPHINE, 5 MG/DAY. EIGHT MONTHS AFTER IDDS REPLACEMENT, THE PATIENT EXPERIENCED RE-EMERGING SEVERE PAIN RADIATING DIFFUSELY TO HER LEFT LEG AND RATED BY THE PATIENT 9 ON A NUMERIC PAIN RATING SCALE (0¿10). SHE LATER NOTICED SLIGHT WEAKNESS OF HER LEFT LEG. CLINICAL EXAMINATION REVEALED DECREASED RANGE OF MOTION OF THE LOW BACK, INTENSIVE PAIN IN THE THORACOLUMBAR SPINE WITH EXACERBATION DURING INCLINATION TO THE LEFT, LEFT PATELLAR HYPERREFLEXIA, AND DYSESTHESIAS WITH MILD HYPESTHESIA IN THE LEFT LOWER EXTREMITY DISTAL TO THE INGUINAL LIGAMENT. ACHILLES TENDON REFLEXES WERE WEAK BILATERALLY. C-REACTIVE PROTEIN, BLOOD COUNT, ANTIBODIES AGAINST BORRELIA AND OTHER ROUTINE BIOCHEMICAL SERUM STUDIES WERE WITHIN NORMAL RANGE. THE TIP OF THE CATHETER WAS LOCATED AT THE T11 LEVEL BY PLAIN RADIOGRAPHS. CONVENTIONAL MOTOR NERVE CONDUCTION STUDIES WERE NORMAL IN PERONEAL AND TIBIAL NERVES INCLUDING NORMAL F WAVES. SURAL NERVE CONDUCTION VELOCITY WAS NORMAL. THERE WAS NO SPONTANEOUS ACTIVITY IN LEFT QUADRICEPS, TIBIALIS ANTERIOR, SOLEUS, AND T11/12 PARASPINAL MUSCLES ON CONCENTRIC NEEDLE EMG. DISCRETE CHRONIC NEUROGENIC CHANGES (INCREASED POLYPHASICITY AND HIGH AMPLITUDE MOTOR UNIT POTENTIALS) IN LEFT TIBIAL ANTERIOR MUSCLE CONCURRED WITH CHRONIC L5 RADICULOPATHY. TIBIAL NERVE STIMULATION ELICITED CORTICAL SEPS OF ABNORMAL LATENCY AND AMPLITUDE BILATERALLY (RIGHT SIDE STIMULATION: P37 LATENCY, 46.0 MS; P37¿N45 AMPLITUDE, 1.1 V; LEFT SIDE STIMULATION: P37 LATENCY, 50.8 MS; P37¿N45 AMPLITUDE, 0.9 V) CONSISTENT WITH DORSAL COLUMN DYSFUNCTION. REPEAT MRI ON A 1.5 TESLA SCANNER (SYMPHONY, SIEMENS, GERMANY) USING A SPECIAL SURFACE COIL DISCLOSED AN INTRADURAL EXTRAMEDULLARY LESION AT THE TH11/12 LEVEL WITH SPINAL CORD COMPRESSION AND T2 SIGNAL HYPERINTENSITY THAT CONFIRMED MYELOPATHY. MODEST DEGENERATIVE SPONDYLOGENIC STENOSIS, HYPERTROPHY OF INTERVERTEBRAL JOINTS AND LIGAMENTS WERE PRESENT AT THE THORACOLUMBAR REGION, WITH MAXIMUM AT THE L2/3 LEVEL. THE PATIENT UNDERWENT DECOMPRESSIVE HEMILAMINECTOMY AND RESECTION OF AN ADHERENT FIBROTIC MASS ATTACHED TO THE SPINAL CORD AND TO THE TIP OF THE INTRATHECAL CATHETER. HISTOLOGICAL INVESTIGATION OF THE REMOVED SPECIMEN REVEALED AN INFLAMMATORY MASS WITH LYMPHOPLASMOCYTIC INFILTRATION WITHOUT NEUTROPHILIC GRANULOCYTES IN FIBROUS TISSUE WITH FIBRIN-RICH BACKGROUND. THERE WAS NO EVIDENCE OF MALIGNANCY, AND NO PATHOGENIC MICRO-ORGANISMS COULD BE IDENTIFIED. THE SPINAL CATHETER WAS SHORTENED SO AS TO END 2 CM BELOW THE LEVEL OF COMPRESSION. THE PATIENT RECOVERED WELL AFTER SURGERY, PAIN SUBSIDED PROMPTLY, WHILE THE MILD WEAKNESS IN HER LEFT LOWER LIMB HAVE IMPROVED ONLY SLOWLY OVER TIME. POSTOPERATIVE MRI AT 3 AND 6 MONTHS SHOWED NO RESIDUAL FIBROTIC MASS BUT THE INTRASPINAL T2 SIGNAL HYPERINTENSITY AT THE LEVEL OF SPINAL CORD COMPRESSION WAS STILL PRESENT. THE PATIENT WAS SUCCESSFULLY CONTINUED ON MORPHINE, FLOW RATE OF 0.25 ML/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340588 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention