BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 12493393 · Received September 18, 2021

    Report

    Report Number
    2182207-2021-01612
    Event Type
    Injury
    Date Received
    September 18, 2021
    Date of Event
    May 4, 2021
    Report Date
    September 18, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709SC, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: EHSANIAN R, KOSHKIN E, GOINS AE, MONTERA MA, ALLES S. PRE- AND POST-INTERVENTIONAL CHANGES IN PHYSIOLOGICAL PROFILES IN A PATIENT PRESENTING WITH OPIOID WITHDRAWAL AFTER INTRATHECAL DRUG DELIVERY SYSTEM FAILURE RELATED TO ASSUMED CATHETER MICROFRACTURE. CUREUS. 2021;13(5):E14835.10.7759/CUREUS.14835 SUMMARY: THE INTRATHECAL DRUG DELIVERY SYSTEM (IDDS) IS SUCCESSFULLY UTILIZED FOR THE TREATMENT OF CHRONIC PAIN CONDITIONS; HOWEVER, THEY ARE ASSOCIATED WITH COMPLICATIONS RELATED TO HUMAN ERROR AND SYSTEM FAILURE. A CASE REPORT IS PRESENTED OF A PATIENT WITH OPIOID WITHDRAWAL (OW) SECONDARY TO ASSUMED CATHETER MICROFRACTURE. INTERROGATION OF THE IDDS ALLOWED FOR THE COLLECTION OF PRE- AND POST-TREATMENT/STABILIZATION CEREBROSPINAL FLUID (CSF), WHICH IS USED TO INVESTIGATE THE POSSIBLE PHYSIOLOGICAL DETERMINANTS OF OW. A (B)(6) YEAR-OLD FEMALE WITH A HISTORY OF LOW BACK PAIN AFTER TRAUMATIC LOW BACK INJURY STATUS POST-IDDS PLACEMENT FOR FAILED BACK SURGERY SYNDROME PRESENTED WITH SIGNS AND SYMPTOMS CONCERNING FOR OW. AFTER EVERY OTHER POSSIBLE EXPLANATION WAS RULED OUT, IT WAS HYPOTHESIZED THAT THERE MAY BE IDDS CATHETER MICROFRACTURE(S), AND CATHETER REPLACEMENT LED TO SYMPTOM RESOLUTION. THERE WERE NO SIGNIFICANT DIFFERENCES IN CYTOKINE LEVELS TESTED IN PRE-CSF VERSUS POST-CSF SAMPLES. WHOLE-CELL PATCH-CLAMP ELECTROPHYSIOLOGY ANALYSIS OF HUMAN-INDUCED PLURIPOTENT STEM CELL-DERIVED NOCICEPTORS AFTER TREATMENT WITH PRE- AND POST- CSF SAMPLES DEMONSTRATED MODULATION OF ACTION POTENTIAL WAVEFORM. IN PATIENTS PRESENTING WITH ACUTE OW ATTRIBUTION IDDS MALFUNCTION, CATHETER MICROFRACTURE MUST BE IN THE DIFFERENTIAL, AND NON-CONVENTIONAL INTERROGATION OF THE IDDS CATHETER SHOULD BE CONSIDERED. THE POSSIBLE DIFFERENCES IN PRE-CSF AND POST-CSF MAY BE MORE COMPLICATED THAN PREVIOUSLY POSTULATED, AS THERE WERE NO SIGNIFICANT DIFFERENCES IN CYTOKINE PROFILES; HOWEVER, TREATMENT OF IN VITRO NEURONS WITH PRE- AND POST-CSF RESULTED IN DIFFERENTIAL NEURONAL EXCITABILITY, WHICH MAY ACCOUNT FOR SOME OF THE SYMPTOMS OF OW. REPORTED EVENTS: A (B)(6) YEAR-OLD FEMALE POST-IDDS PLACEMENT FOR FAILED BACK SURGERY SYNDROME PRESENTED FOR SIGNS AND SYMPTOMS CONCERNING FOR OW. THE PATIENT¿S PAIN HAD INCREASED FROM HER BASELINE OF 2/10 TO 9/10. SHE COMPLAINED OF APPROXIMATELY 24 HOURS OF INSOMNIA, ANXIETY, SEVERE TREMORS, BILATERAL LOWER EXTREMITY MYALGIAS AND ARTHRALGIA, NAUSEA, NON-BLOODY EMESIS, DIARRHEA, AND SENSATION OF BEING FLUSHED. SHE DENIED ANY NEW FOCAL NEUROLOGICAL SYMPTOMS. HER CLINICAL OPIATE WITHDRAWAL SCALE SCORE WAS 27 (MODERATELY SEVERE) [18]. VITAL SIGNS WERE SIGNIFICANT FOR A BLOOD PRESSURE OF 125/104 MM HG, A PULSE OF 125 BEATS PER MINUTE, AND A RESPIRATORY RATE OF 23 BREATHS PER MINUTE. SHE REPORTED ONLY TAKING HYDROCHLOROTHIAZIDE FOR CHRONIC HYPERTENSION AT HOME. THE PUMP WAS PROGRAMMED TO BOLUS 60 MCG FENTANYL/0.75 MG BUPIVACAINE OVER TWO MINUTES WITHOUT RELIEF. SHE RECEIVED 4 MG INTRAVENOUS (IV) HYDROMORPHONE FOLLOWED BY 50 MCG IV FENTANYL IN THE EMERGENCY ROOM. SHE REPORTED THAT HER SYMPTOMS SOMEWHAT IMPROVED WITH THE IV MEDICATIONS, BUT SHE CONTINUED TO BE IN VISIBLE DISTRESS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON THE NIGHT OF PRESENTATION FOR CATHETER DYE STUDY (FIGURE 1), PUMP ROLLER STUDY, AND RESERVOIR CHECK. ¿PRE-TREATMENT¿ CSF SAMPLE WAS ATTAINED AT THIS TIME. NO CATHETER LEAKS WERE VISUALIZED (FIGURES 1B-1F), AND THE ROTOR STUDY DEMONSTRATED CORRECT PUMP FUNCTION (FIGURE 1A) WITH NO ERROR MESSAGES FROM PUMP INTERROGATION. THE CATHETER TIP WAS AT THE T9 LEVEL, WITH NO EVIDENCE OF CATHETER MIGRATION (FIGURE 1F). THE CONTRAST LAYERED IN A GRAVITY-DEPENDENT MANNER IN THE THECAL SPACE WITHOUT RADIOGRAPHIC EVIDENCE OF GRANULOMA (FIGURE 1F). AFTER EVERY OTHER POSSIBLE EXPLANATION WAS RULED OUT, IT WAS HYPOTHESIZED THAT SIGNS AND SYMPTOMS MAY BE SECONDARY TO CATHETER MICROFRACTURE, AND THE PATIENT WAS SCHEDULED FOR CATHETER REPLACEMENT. WHILE WAITING TO RETURN TO THE OPERATING ROOM, HER SCHEDULED AND PRN (PRO RE NATA) MEDICATIONS INCLUDED IV HYDROMORPHONE PATIENT-CONTROLLED ANALGESIA 0.5 MG, IV HYDROMORPHONE 0.5 MG, CLONIDINE 0.1 MG PO (ORAL), IV DIPHENHYDRAMINE 12.5 MG, AND IV ATIVAN 1 MG. THE FOLLOWING DAY, OW SYMPTOMS HAD RESOLVED. THE PATIENT UNDERWENT A POCKET REVISION OF ITP AND CATHETER REIMPLANTATION (FIGURE 2 ). ¿POST-TREATMENT¿ CSF SAMPLE WAS ATTAINED AT THIS TIME. PAIN WAS SUCCESSFULLY CONTROLLED WITH THE IDDS AFTER A NEW CATHETER WAS IMPLANTED, AND THE PATIENT HAS NOT REQUIRED FURTHER PO PAIN MEDICATIONS SINCE THE REVISION. IN THIS CASE STUDY, WE PRESENT THE FIRST CASE REPORT OF A PATIENT UNDERGOING ACUTE OW SECONDARY TO ASSUMED CATHETER MICROFRACTURE. WE SUSPECT MICROFRACTURE OF THE CATHETER, AS LIVE FLUOROSCOPIC INTERROGATION OF THE IDDS REVEALED NO MALFUNCTION OF THE PUMP (AS THE PUMP MOTOR WAS INTERROGATED AND OBSERVED TO TURN APPROPRIATELY), NO ISSUES WITH CATHETER PATENCY (AS CSF WAS ASPIRATED FROM THE ACCESS PORT), NO CONTRAST LEAKAGE AT THE CATHETER CONNECTION SITE AS WELL AS NO CONTRAST LEAKAGE ALONG THE LENGTH OF THE CATHETER (WITH LIVE FLUOROSCOPY AND DIGITAL SUBTRACTION IMAGING), AND NO SUBDURAL EXTRAVASATION AT THE CATHETER TIP. MOREOVER, THE CONTRAST PATTERN AT THE TIP OF THE CATHETER RULED OUT THE POSSIBILITY OF OCCLUSION AT THE TIP BY GRANULOMA FORMATION. THE MOST CONVINCING EVIDENCE EXCLUDING THE MEDTRONIC SYNCHROMED II PUMP AND IMPLICATING CATHETER MALFUNCTION WAS THE LASTING RESOLUTION OF SYMPTOMS UPON CATHETER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390765 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R