BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3605118 · Received February 4, 2014

    Report

    Report Number
    3007566237-2014-00361
    Event Type
    Injury
    Date Received
    February 4, 2014
    Report Date
    January 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN, LOT# UNKNOWN, PRODUCT TYPE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    KOCHANY, J. Z., TRAN, N. D., SARRIA, J. E. INCREASING BACK AND RADICULAR PAIN 2 YEARS FOLLOWING INTRATHECAL PUMP IMPLANTATION WITH REVIEW OF ARACHNOIDITIS. PAIN MEDICINE (MALDEN, MASS.). 2013;14(11):1658-1663. SUMMARY: IMPLANTED INTRATHECAL DRUG DELIVERY PUMPS ARE NOW REGULARLY USED FOR THE TREATMENT OF CHRONIC BENIGN AND CANCER-RELATED PAIN THAT IS REFRACTORY TO CONSERVATIVE TREATMENT METHODS. IN MOST CASES, THE PUMPS ARE SUCCESSFUL AT REDUCING THE INTENSITY OF PAIN AND IMPROVING FUNCTION AND QUALITY OF LIFE FOR PAIN PATIENTS. LIMITED STUDIES HAVE DISCUSSED THE COMPLICATIONS ASSOCIATED WITH INTRATHECAL PUMP PLACEMENT WE DESCRIBE AN UNUSUAL CASE OF A PATIENT WHO PRESENTED WITH PROGRESSIVE WEAKNESS AND WORSENING LUMBAR AND LOWER EXTREMITY PAIN FOLLOWING IMPLANTATION OF AN INTRATHECAL DRUG DELIVERY SYSTEM (IDDS). WORK-UP FOR THE PATIENT¿S SYMPTOMS INCLUDES A MAGNETIC RESONANCE IMAGING, WHICH REVEALED LUMBAR ARACHNOIDITIS. PATIENT UNDERWENT A LAMINECTOMY AND DETETHERING OF SPINAL CORD AND NERVE ROOTS BELOW LEVEL OF CATHETER INSERTION. THERE WAS TRANSIENT IMPROVEMENT IN HER PAIN AND WEAKNESS. SUBSEQUENT SURGERY FOR PUMP EXPLANTATION REVEALED A RETAINED TOUHY INTRODUCER NEEDLE FROM HER PUMP PLACEMENT PROCEDURE. THE ENTIRE IDDS WAS REMOVED INCLUDING THE RETAINED TOUHY INTRODUCER NEEDLE. THE PATIENT LATER WENT ON TO RECEIVE A SUCCESSFUL SPINAL CORD STIMULATOR TRIAL AND IMPLANTATION WITH MODERATE RELIEF OF HER CHRONIC PAIN. REPORTED EVENT: A (B)(6) OLD FEMALE PATIENT WITH COMPLEX REGIONAL PAIN SYNDROME HAD A PROLONGED POSTOPERATIVE COURSE DUE TO POSTURAL HEADACHES. THIS WAS PRESUMED TO BE DUE TO CEREBROSPINAL FLUID (CSF) LEAKAGE AROUND THE CATHETER FOR WHICH SHE WAS TREATED WITH AN EPIDURAL BLOOD PATCH ON TWO SEPARATE OCCASIONS. HER POSTURAL HEADACHES EVENTUALLY RESOLVED; HOWEVER, HER PAIN PROGRESSED DESPITE INTRATHECAL INFUSIONS OF MORPHINE AND BUPIVICAINE. THE PATIENT DEVELOPED NEW RIGHT HIP AND GROIN PAIN, AS WELL AS LOWER EXTREMITY WEAKNESS SHORTLY AFTER IMPLANTATION. THE DOSING OF INTRATHECAL MORPHINE WAS LATER DECREASED AND THE BUPIVICAINE DISCONTINUED BY A SECOND PHYSICIAN. PATIENT PRESENTED TO THE PAIN MEDICINE CLINIC WITH COMPLAINTS OF CHRONIC LOW BACK, RIGHT HIP AND BILATERAL LOWER EXTREMITY BURNING PAIN, AND INCREASING WEAKNESS AS WELL AS URINARY RETENTION. ON PRESENTATION, SHE WAS NOTED TO BE ANXIOUS AND EMOTIONAL WITH SUICIDAL IDEATIONS. SHE HAD EXQUISITE TENDERNESS TO PALPATION OF THE MIDLINE LUMBAR SPINE REGION, ALTHOUGH SHE DID HAVE GENERALIZED PAIN OF ALL LUMBAR PARASPINALS. HER CLINICAL EXAM WAS SEVERELY LIMITED DUE TO PAIN. MUSCLE STRENGTH TESTING REVEALED GENERALIZED WEAKNESS, 4/5 THROUGHOUT BOTH LOWER EXTREMITIES. HER PUMP AT FIRST VISIT WAS INTERROGATED SHOWING A DAILY INFUSION RATE OF 1.5 MG/DAY OF MORPHINE WITHOUT EVIDENCE OF PREVIOUS STALLS IN THE LOG. THE INFUSION WAS THEN INCREASED TO 2.4 MG/DAY. ONE MONTH LATER, THE DOSE WAS INCREASED TO 2.79 MG/DAY AND SUBSEQUENTLY 2 MONTHS LATER TO 3.09 MG/DAY WITHOUT SUFFICIENT ANALGESIA. LUMBAR SPINE MRI WAS OBTAINED, DEMONSTRATING A LINEAR SUSCEPTIBILITY ARTIFACT EXTENDING HORIZONTALLY FROM THE SUBCUTANEOUS SOFT TISSUES TO THE L2 VERTEBRAL BODY INTERPRETED TO BE THE INTRATHECAL CATHETER. OTHER SIGNIFICANT FINDINGS INCLUDED CLUMPING OF THE NERVE ROOTS AT THE L3¿4 LEVEL THAT SUGGESTED ARACHNOIDITIS (FIGURES 1, 2). A NEUROSURGICAL EVALUATION CONFIRMED THE DIAGNOSIS OF ARACHNOIDITIS WITH TETHERED CORD SYNDROME, AND THE PATIENT WAS OFFERED SURGERY FOR DETETHERING OF HER SPINAL CORD AND NERVE ROOTS. LOCALIZING FLUOROSCOPIC IMAGES AT THE TIME OF SURGERY REVEALED A SUSPICIOUS SHARPLY DEFINED RADIOOPACITY OF THE CATHETER. THE DECISION WAS MADE TO NOT EXPLORE THE CATHETER AT THE TIME OF SURGERY IN ORDER TO PREVENT THE RISK OF PERSISTENT CSF LEAKAGE OR CATHETER INFECTION. INTRAOPERATIVE FINDINGS REVEALED BLOOD TINGED CSF AND HEMOSIDERIN-STAINED THECAL SAC. THE NERVE ROOTS THAT WERE CLUMPED AND TETHERED TO THE THECAL SAC WERE SUCCESSFULLY DETHETERED. IN THE POSTOPERATIVE PERIOD, THE PATIENTDEMONSTRATED SIGNIFICANT IMPROVEMENT IN HER PAIN AND WEAKNESS. SHE WAS ABLE TO WALK WITH MINIMAL ASSISTANCE; HOWEVER, THE PATIENT¿S PAIN AND WEAKNESS RETURNED TO BASELINE AFTER SEVERAL WEEKS. SHE WAS SCHEDULED FOR EXPLORATION AND EXPLANTATION OF HER IDDS SHORTLY AFTER. IN THE ANTERIOR POCKET, THE ENTIRE CATHETER WITH THE TIP STILL INTACT WAS DISCOVERED WOUND UP BEHIND THE PUMP (FIGURE 3). THE POSTERIOR APPROACH INVOLVED EXTENSIVE DISSECTION THROUGH MORE THAN 30 CM OF ADIPOSE TISSUE TO GAIN ACCESS TO THE DORSOLUMBAR FASCIA. DURING THIS DISSECTION, THE COMMONLY USED BUTTERFLY ANCHOR DEVICE FROM MEDTRONIC IMPLANTATION KITS WAS FOUND SUTURED TO ADIPOSE TISSUE ABOUT 5 CM SUPERFICIAL TO THE FASCIA. . THE PATIENT INITIALLY REPORTED PAIN RELIEF WITH USE OF THE PUMP BUT HAD A LOSS OF EFFICACY. WE SPECULATE THAT THIS MAY BE A RESULT OF ARACHNOIDITIS, AS WELL AS THE DISTAL CATHETER RETRACTING FROM THE DURAL SAC AS IT WAS LOOSELY ANCHORED TO THE ADIPOSE TISSUE. AS THE DORSOLUMBAR FASCIA WAS APPROACHED, WE IDENTIFIED THE PROXIMAL END OF A TOUHY NEEDLESITTING ABOVE THE THORACOLUMBAR FASCIA AND EXTENDING VENTRALLY TOWARD THE SPINAL CANAL (FIGURE 4). THE PUMP, TOUHY INTRODUCER NEEDLE, AND INTRATHECAL CATHETER WERE REMOVED WITHOUT COMPLICATIONS. THE PATIENT RECOVERED UNEVENTFULLY WITH RESOLUTION OF HER HIP PAIN. IN SPITE OF THIS, SHE HAS CONTINUED TO SUFFER INCAPACITATING PAIN. A SPINAL CORD STIMULATOR WAS TRIALED AND IMPLANTED, PROVIDING MODERATE CONTROL OF HER SYMPTOMS. AT 1-YEAR FOLLOW-UP, SHE CONTINUES TO DO WELL WITH IMPROVEMENTS IN PAIN AND LOWER EXTREMITY STRENGTH. SHE IS NOW AMBULATORY AND WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73237 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention