BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 9263036 · Received October 31, 2019

    Report

    Report Number
    3007566237-2019-02254
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    April 1, 2018
    Report Date
    October 31, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, LOT#: UNKNOWN, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN. HAERING, M., SALEH, C., JASZCZUK, P., KOEHLER, M., HUND-GEORGIADIS, M. INTRATHECAL PUMP CATHETER-TIP GRANULOMA RECURRENCE WITH ASSOCIATED MYELOMALACIA - HOW SAFE IS INTRATHECAL ANALGESIC INFUSION THERAPY? A CASE REPORT. SURGICAL NEUROLOGY INTERNATIONAL. DOI: 10.25259/SNI-33-2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    SUMMARY: INVASIVE NONMALIGNANT PAIN MANAGEMENT WITH INTRATHECAL (IT) ANALGESIC INFUSION THERAPY IS A COMMON STRATEGY FOR THE TREATMENT OF ¿FAILED BACK SURGERY SYNDROME¿ (FBSS). CATHETER-TIP ASSOCIATED GRANULOMAS ARE A KNOWN BUT RARE COMPLICATION OF IT ANALGESIC INFUSION THERAPY WITH POTENTIALLY SEVERE NEUROLOGICAL CONSEQUENCES OCCURRING IN < 3% OF MORPHINE PUMP PATIENTS. DUE TO THE INCREASING FREQUENCY OF IT MORPHINE PUMP IMPLANTATION AS A MANAGEMENT STRATEGY FOR CHRONIC PAIN DUE TO FBSS, THE FAST RADIOLOGICAL DETECTION AND SURGICAL DECOMPRESSION OF SUCH LESIONS ARE PARAMOUNT TO NEUROLOGICAL PRESERVATION. REPORTED EVENTS: IT WAS REPORTED A PATIENT HAD A RECURRENCE OF A CATHETER-TIP GRANULOMA CAUSING A HIGH-GRADE PARESIS OF THE LOWER EXTREMITIES. A (B)(6)-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF MULTIPLE SPINE SURGERIES, CHRONIC PAIN SYNDROME (CERVICALGIA AND LUMBALGIA), AND A SLIGHTLY ATAXIC GAIT WAS TREATED WITH IT MORPHINE AND CLONIDINE INFUSION (SYNCHROMED II PUMP MEDTRONIC) SINCE 2012. IN (B)(6) 2018, SHE PRESENTED WITH NEW-ONSET PARESTHESIA SUB-T5. A MAGNETIC RESONANCE IMAGING (MRI) OF THE SPINE SHOWED HIGH-GRADE COMPRESSION OF THE SPINAL CORD (WITH COMPRESSION INDUCED MYELOMALACIA) AT T3¿T5 CORRESPONDING TO THE LOCATION OF THE CATHETER TIP WITH SUSPICION OF A CATHETER-TIP-ASSOCIATED GRANULOMA. A RIGHT-SIDED HEMILAMINECTOMY OF T4 AS WELL AS A PARTIAL HEMILAMINECTOMY OF T3 AND T5 WAS PERFORMED. THE EXPOSED DURA WAS THICKENED AND ADHERENT TO THE SURROUNDING STRUCTURES. AFTER REMOVAL OF THE ADHESIONS AND PREPARATION OF THE DURA, A NECROTIC-SEEMING CENTRAL THICKENING, CONTINUOUS WITH THE SURROUNDING NORMAL DURA, WAS IDENTIFIED AS THE GRANULOMATOUS MASS. THIS HIGHLY ADHERENT MASS WAS CAREFULLY RESECTED ALONG A CLEARLY DEFINED PLANE BETWEEN THE GRANULOMA AND THE NORMAL DURA. A PARTIAL RESECTION OF THE HEALTHY DURA SURROUNDING THE RIGHT T4 NERVE ROOT WAS REQUIRED. THE CATHETER WAS THEN IDENTIFIED INSIDE THE SPINAL CANAL AND REMOVED. DUE TO ADHERENCE TO THE T4 NERVE ROOT, THE DECISION WAS MADE TO SACRIFICE THE T4 NERVE. THE GRANULOMA WAS THEN CAREFULLY RESECTED ALONG WITH THE DIVIDED NERVE. THE UNDERLYING SPINAL CORD HAD SIGNS OF METAL DEPOSITS FROM THE CATHETER AS WELL AS SIGNS OF MYELOMALACIA. THE SPINAL CORD WAS COMPLETELY DECOMPRESSED, AND THE PRIMARY CLOSURE OF THE DURA WAS POSSIBLE. POST-SURGERY, THE PATIENT SHOWED A MODERATE- TO HIGH-GRADE PROXIMALLY PRONOUNCED PARESIS OF THE RIGHT LOWER EXTREMITY, WHICH SLIGHTLY IMPROVED IN THE DAYS FOLLOWING SURGERY. MRI REVEALED A SATISFACTORY DECOMPRESSION OF THE SPINAL CORD AND REMOVAL OF THE GRANULOMA. HOWEVER, THE MRI SHOWED A MORE MARKED (PREEXISTING) MYELOMALACIA EXTENDING NOW FROM T2 TO T7. ADDITIONAL ORAL ANALGESIA OXYCODONE 5 MG TWICE DAILY AND TRIMIPRAMINE 100 MG ONCE DAILY HAD TO BE CONTINUED UNCHANGED, FOR THE PERSISTENCE OF FOREMOST LUMBAR PAIN. AFTER AN INITIAL STABLE CLINICAL COURSE, SHE COMPLAINED OF INCREASING NEUROPATHIC PAIN INITIALLY LOCATED MOSTLY IN THE T9¿T12 AREA AND SUBSEQUENTLY ASCENDING INTO THE THORAX APPROXIMATELY 2 MONTHS AFTER ADMISSION. PAIN MEDICATION HAD TO BE INCREASED BY ADDING PREGABALIN AND CANNABIS OIL (DROPS) AND INCREASING THE MORPHINE AND CLONIDINE PUMP DOSAGE YET WITHOUT CLINICAL BENEFIT. CLINICALLY, THE PATIENT COMPLAINED OF INSTABILITY AND SENSORY LOSS IN THE LEFT LEG. A LUMBAR MRI WAS PERFORMED, WHICH DID NOT EXPLAIN THE NEW FINDINGS. WITHIN 1 WEEK, THE PATIENT DETERIORATED DRAMATICALLY LOOSING ALMOST ALL MOTOR STRENGTH IN THE LOWER EXTREMITIES. A CERVICAL AND THORACIC MRI SHOWED A MASS SUSPICIOUS FOR A CATHETER-TIP GRANULOMA CAUSING A COMPRESSION OF THE THORACIC SPINE AT T7¿T11 ASSOCIATED WITH A SECONDARY MYELOMALACIA NOW EXTENDING PROXIMALLY TO THE CONUS MEDULLARIS. A LAMINECTOMY OF T6 WAS PERFORMED. THE UNDERLYING TISSUE WAS GRANULOMATOUS, AND THE CATHETER WAS IDENTIFIED WITHIN THE GRANULOMATOUS MASS. THE LESION WAS EXCISED LEAVING A DURAL DEFECT THAT COULD NOT BE REPAIRED WITH PRIMARY CLOSURE. WATERTIGHT CLOSURE WITH A GORE-TEX PATCH WAS ACHIEVED. THE REMAINING CATHETER WAS REMOVED THROUGH A SEPARATE INCISION, AND A NEW CATHETER WAS NOT PLACED. THE HISTOPATHOLOGICAL FINDING SHOWED TYPICAL GRANULOMA TISSUE FORMED BY HISTIOCYTES, GRANULOCYTES, NECROTIC AREAS, AND ABUNDANT HEMORRHAGIC RESIDUES. THE NEUROLOGICAL STATE OF THE PATIENT IMPROVED MILDLY AFTER DEVICE REMOVAL, GRANULOMA EXCISION, AND INTENSE REHABILITATION FOREMOST GAINING SLIGHT-TO-MODERATE MOTOR STRENGTH IN THE LEFT LEG. IN THIS PATIENT, THE RECURRENCE OCCURRED ONLY 5 MONTHS AFTER THE INITIAL GRANULOMA REMOVAL AND CATHETER REPOSITIONING AND WAS ASSOCIATED WITH A MARKED MYELOMALACIA, POSSIBLY CONSEQUENCE OF MYELOCOMPRESSION AND TOXIC DRUG-INDUCED TISSUE ALTERATIONS. A T2 AXIAL IMAGE OF THE LESION SURROUNDING THE CATHETER WAS INCLUDED. THE GRANULOMA APPEARED AS AN EXTRA-AXIAL LESION ISODENSE TO THE MYELON. A T1 CONTRAST SAGITTAL IMAGE WAS INCLUDED, SHOWING A SPACE-OCCUPYING, RING-ENHANCING, INHOMOGENEOUS, EXTRA-AXIAL MASS IN THE SPINAL CANAL AT THE LEVEL OF T4. A T2 SAGITTAL IMAGE OF THE SAME LESION WITH CLEARLY VISIBLE EXTENSIVE T2 SIGNAL CHANGES IN THE SPINAL CORD WAS INCLUDED. THE TIP OF THE CATHETER WAS SEEN ENCASED IN THE GRANULOMA SUBSTANCE. A T1 CONTRAST AXIAL IMAGE SHOWING A LARGE RECURRENCE OVERSHADOWING AND COMPRESSING THE SPINAL CORD WAS INCLUDED. A T1 CONTRAST IMAGE WAS INCLUDED, SHOWING THE RECURRENT GRANULOMA AS A LARGE, RING-ENHANCING, INHOMOGENEOUS, MASS-CAUSING HIGH-GRADE COMPRESSION OF THE SPINAL CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058042 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention