BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 11280683 · Received February 4, 2021

    Report

    Report Number
    2182207-2021-00199
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    August 31, 2020
    Report Date
    February 4, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BSCHORER M, MARTINEZ-MORENO M, TIETKE M, ET AL. (AUGUST 31, 2020) THE MANAGEMENT OF UNRESECTABLE INTRATHECAL CATHETER-TIP-ASSOCIATED GRANULOMA USING MORPHINE THERAPY CESSATION AND SPINAL CORD STIMULATION. CUREUS 12(8): E10160. DOI 10.7759/CUREUS.10160 PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. THE ARTICLE MENTIONED THAT IN 2017, THE PATIENT REPORTED WORSENING LUMBAR PAIN AS WELL AS NEW-ONSET LEFT-SIDED RADICULAR PAIN, BUT PRIOR TO THAT IT MENTIONED THAT "DESPITE AN INITIALLY POSITIVE RESPONSE TO ITMS THERAPY, PROGRESSIVELY HIGHER DOSES OF MORPHINE SULFATE WERE REQUIRED" FOR WHICH THE DATE OF ONSET WAS NOT SPECIFIED. SECTION D: ALTHOUGH THE ARTICLE DID NOT SPECIFICALLY PROVIDE THE MODEL NUMBER OR BRAND NAME OF THE PUMP (OR CATHETER), BASED ON THE IMAGES OF THE X-RAY OF THE DEVICE THE MANUFACTURER HAS IDENTIFIED THAT THE DEVICE IS LIKELY A MODEL 8637 SYNCHROMED II PUMP. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, LOT#: UNKNOWN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BELOW IS THE ABSTRACT AND INFORMATION ABOUT THE REPORTED EVENT: ABSTRACT: CATHETER-TIP-ASSOCIATED GRANULOMAS (CTG) ARE A RARE BUT SERIOUS COMPLICATION OF INTRATHECAL ANALGESIC DELIVERY PUMPS (IADP), WHICH INTERFERE WITH PAIN MODULATION AND CAN CAUSE IRREVERSIBLE NEUROLOGIC DEFICITS. THE TREATMENT OF SYMPTOMATIC CTG GENERALLY INVOLVES SURGICAL RESECTION AND CATHETER REMOVAL. WE PRESENT A CASE OF AN UNRESECTABLE CTG, WHICH WE MANAGED USING PROGRESSIVE LOWERING OF THE INTRATHECAL MORPHINE SULFATE (ITMS) DOSAGE AS WELL AS SPINAL CORD STIMULATION (SCS). A (B)(6) YEAR-OLD FEMALE WITH FAILED BACK SURGERY SYNDROME (FBSS) PRESENTED WITH NEW-ONSET LEFT-SIDED LUMBAR RADICULOPATHY AFTER FIVE YEARS OF MODERATELY SUCCESSFUL ITMS THERAPY. (B)(6) STUDY SUGGESTED AN UNKNOWN MASS ASSOCIATED WITH THE TIP OF THE CATHETER. THE TUMOR¿S ADHERENCE TO NERVE ROOTS OF THE CONUS TERMINALIS PREVENTED A COMPLETE RESECTION AND ONLY ALLOWED FOR A BIOPSY. AFTER THE SCS IMPLANTATION, WE PROGRESSIVELY LOWERED THE ITMS DOSE. IN A FOLLOW-UP CONSULTATION, THE PATIENT REPORTED THE REGRESSION OF THE RADICULOPATHY AS WELL AS SATISFACTORY PAIN LEVELS WITHOUT ORAL OPIATES. IN THIS CASE OF CTG, CESSATION OF INTRATHECAL MORPHINE PREVENTED THE FURTHER GROWTH OF THE GRANULOMA. SCS EFFECTIVELY ADDRESSED BOTH THE CHRONIC LUMBAR BACK PAIN AS WELL AS THE NEW-ONSET RADICULAR PAIN CAUSED BY THE CTG. REPORTED EVENT(S): A (B)(6) YEAR-OLD FEMALE WITH CHRONIC BACK PAIN DUE TO FAILED BACK SURGERY SYNDROME (FBSS) AND A HISTORY OF ORAL OPIATE DEPENDENCY PRESENTED WITH A CTG. THE PATIENT INITIALLY UNDERWENT COMBINED VENTRAL AND DORSAL SPINAL FUSION OF THE L4 AND L5 VERTEBRAE IN 2005 AFTER A DECADE OF PERSISTENT LOWER BACK PAIN DUE TO EXTENSIVE OSTEOCHONDROSIS. FIVE YEARS LATER, THE PATIENT RECEIVED SURGICAL TREATMENT FOR A HERNIATED SPINAL DISC AT LEVELS L5-S1. DUE TO ADJACENT SEGMENT DEGENERATION, THE PATIENT UNDERWENT L5-S1 SPINAL FUSION TWO YEARS LATER (FIGURE 1A). IN 2013, THE PATIENT UNDERWENT IMPLANTATION OF AN IADP AND RECEIVED ITMS WITH SATISFACTORY PAIN RELIEF (FIGURE 1B). DESPITE AN INITIALLY POSITIVE RESPONSE TO ITMS THERAPY, PROGRESSIVELY HIGHER DOSES OF MORPHINE SULFATE WERE REQUIRED, UP TO A DAILY DOSE OF 4.8 MG WITH A CONCENTRATION OF 20 MG/ML. IN 2017, THE PATIENT REPORTED WORSENING LUMBAR PAIN AS WELL AS NEW-ONSET LEFT-SIDED RADICULAR PAIN. AN MRI SCAN REVEALED A HOMOGENOUS CONTRAST AGENT ENHANCEMENT OF SOFT TISSUE IN CLOSE RELATION WITH THE TIP OF THE CATHETER (FIGURE 1C). THE FINDINGS SUGGESTED AN INFLAMMATORY GRANULOMATOUS MASS. THE INITIAL TREATMENT INVOLVED THE REDUCTION OF THE MORPHINE SULFATE CONCENTRATION WITHIN THE PUMP TO 10 MG/ML. UNFORTUNATELY, THE RADICULAR PAIN CONTINUED TO WORSEN, AND THE PATIENT DEVELOPED WEAKNESS OF THE LEFT LEG. THE PATIENT AGREED TO A SURGICAL EXPLORATION OF THE LESION FOR NEURAL DECOMPRESSION AND HISTOPATHOLOGICAL CONFIRMATION. THE STRONG ADHERENCE OF THE MASS TO NEURAL STRUCTURES PREVENTED A SAFE RESECTION, ONLY ALLOWING FOR A BIOPSY. A CATHETER-TIP-ASSOCIATED GRANULOMATOUS MASS WAS THEN CONFIRMED. DESPITE THE RECOMMENDATION FOR THE DISCONTINUATION OF ITMS THERAPY AND SUBSTITUTION WITH ORAL OPIATES, THE PATIENT REFUSED DUE TO HER HISTORY OF ORAL OPIATE DEPENDENCY. THE SEVERITY OF THE PAIN DID NOT PERMIT LOWER DAILY DOSES OF ITMS. WE CONTINUED USING A 10 MG/ML MORPHINE¿S CONCENTRATION, BUT THIS ACHIEVED NEITHER A REDUCTION IN THE SIZE OF THE CTG NOR AN IMPROVEMENT OF THE CLINICAL SYMPTOMS. A TRIAL OF SCS WAS SUGGESTED TO TREAT THE CTG-ASSOCIATED SYMPTOMS AS WELL AS THE CHRONIC LUMBAR PAIN RELATED TO FBSS. AFTER A SUCCESSFUL TRIAL, THE PATIENT UNDERWENT IMPLANTATION OF A NEUROMODULATION DEVICE IN 2018 (FIGURES 1D, 1E). A PARAESTHESIA-BASED STIMULATION PROGRAM (INTENSITY 13.5 MA, PULSE DURATION 580 ¿S, AND FREQUENCY 50 HZ) PROVIDED LASTING PAIN RELIEF. OVER THE COURSE OF THE NEXT THREE MONTHS, THE PATIENT REQUIRED PROGRESSIVELY LOWER DOSES OF ITMS UNTIL COMPLETE CESSATION OF INTRATHECAL OPIATE THERAPY. A FOLLOW-UP MRI SCAN IN 2020 REVEALED A REDUCTION IN THE SIZE OF THE GRANULOMA, AND THE PATIENT HAS BEEN ABLE TO REMAIN WITHOUT ORAL OPIOID ANALGESICS (FIGURE 1F).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179356 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention