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Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Headache (1880); Inflammation (1932); Muscle Weakness (1967); Muscular Rigidity (1968); Undesired Nerve Stimulation (1980); Pain (1994); Visual Disturbances (2140); Meningitis (2389); Spinal Cord Injury (2432); Ambulation Difficulties (2544); Fibrosis (3167); Skin Inflammation/ Irritation (4545); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/01/2019
Event Type  Injury  
Manufacturer Narrative
Literature citation: inbarasu jd, hagedorn jm. Subdural cervical spinal cord stimulator lead placement leading to progressive neurologic symptoms. Neuromodulation. 2020. 10. 1111/ner. 13296 literature summary: spinal cord stimulation (scs) is increasingly used to treat various chronic painful conditions, including intractable angina pectoris. Risks previously described with scs at any spinal level include lead migration, neural irritation or injury, dural puncture and subsequent headache, neuraxial bleeding, lead fracture or failure, infection, hardware malfunction, and unwanted stimulation. A prior case report described an inadvertent subdural lead placement with scs that was identified by variances in lead impedance values, but to our knowledge, no cross-sectional imaging finding or direct intraoperative visual confirmation of this complication has been reported. We describe a case of subacute neurologic symptom development following subdural placement of a cervical scs lead. Being cognizant of this potential complication can facilitate recognition and earlier treatment to prevent further neurologic sequelae. Date of event: please note the event date is approximate. For additional information. Concomitant medical products: product id: neu_unknown_lead, lot#: unknown, implanted: (b)(6) 2011 [approximate], explanted: (b)(6) 2020, product type: lead. Product id: 977a2, lot#: unknown, implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead. Product id: neu_unknown_lead, serial/lot #: unknown, ubd: asku, udi#: asku. Product id: 977a2, serial/lot #: unknown, ubd: asku, udi#: asku. If information is provided in the future, a supplemental report will be issued.
Event Description
It was reported that a (b)(6)-year-old male presented to the emergency department in (b)(6) 2020 after three months of progressive left-sided neck and occipital pain and stiffness beginning after revision of his cervical scs system. Past medical history was notable for coronary artery disease with percutaneous coronary intervention and stenting 12 years prior, as well as two nontraumatic perimesencephalic subarachnoid hemorrhages 30 years and seven years prior to presentation without identified aneurysms on conventional four-vessel cerebral angiography. He had initially undergone implantation of a paresthesia based scs system nine years prior, after a successful trial for refractory angina pectoris. Review of the initial post-implantation anterior¿posterior (ap) fluoroscopic images revealed two percutaneously placed epidural scs leads with the most cephalad electrode of one lead at the level of the mid-c6 vertebral body with left paramedian bias and the second in the midline with the most cephalad electrode at the caudal aspect of the c6 vertebral body. Approximately 11 months prior to presentation to the emergency department, the patient reported less pain relief from the scs system. Reprogramming the system led to brief improvement in pain relief, lasting two to three weeks. The patient underwent exchange of the existing implanted pulse generator (ipg), and intraoperatively, it was noted that one of the leads had elevated impedance levels outside of the device manufacturer¿s normal operating parameters, and several electrodes were nonfunctional. No lead manipulation was performed, and a decision was made to proceed with stimulation of only the normally functioning lead. Despite pain relief of his typical left-sided anginal equivalent chest pain with the exchange of the ipg, the patient experienced undesired head and neck paresthesias when stimulation was turned on and/or when he held his neck in a flexed position. He denied any trauma, accidents, or other events following this surgery. He subsequently underwent magnetic resonance imaging (mri) of the cervical spine, which identified that one of the scs leads was in the ventral epidural space, with the other lead in the dorsal epidural space. Based on these results and to optimize pain relief without the experience of dysesthesias, the patient underwent revision of the system, with removal of the existing leads and attempted replacement of the leads three months prior to presentation in the emergency department. During the revision surgery, only one lead was placed as the second lead was unable to be advanced without the patient experiencing dysesthesias or migrating into the ventral epidural space. On review of the patient¿s prior stimulation location and parameters, the single scs lead was placed cephalad to the prior implant to better cover the involved areas. Intraoperative paresthesia mapping of the single lead successfully covered the area of left-sided chest pain, with impedance values of the lead within manufacturer¿s normal operating limits. Ap fluoroscopic imaging showed a single left paramedian scs lead, and lateral imaging showed dorsal location of the single lead in the spinal canal. No operative complications were noted. The patient was brought to the post-anesthesia care unit without issue and discharged home that s ame day. Initially, the patient¿s postprocedural course was uneventful. His incisions healed well, and he was getting appropriate pain relief. Impedances remained within normal limits during the follow-up visits. Unfortunately, the patient reported gradual onset and progressively worsening left-sided neck pain, headache, and photophobia that began approximately two months after his lead revision procedure. He was instructed to turn off his scs system, but this did not improve his symptoms. Examination revealed meningismus, 4/5 strength in the left upper and lower limbs, and a wide-based unsteady gait. Ct head and cervical spine was performed and revealed a left dorsolateral hyperdense mass at c5 adjacent to the scs lead. Serum laboratory studies revealed normal leukocyte count and normal lactate. Lumbar puncture was obtained due to concern for meningitis and resulted in cloudy-appearing fluid with 91 total nucleated cells per high-powered field, with 49% neutrophils, 241 protein mg/dl, glucose 21 mg/dl, 4000 erythrocytes, and presence of xanthochromia. The cerebrospinal fluid profile was most compatible with aseptic meningitis, with possible blood products in the intrathecal space. He was admitted to the neurology service and received 48 hours of empiric antimicrobial coverage with vancomycin, cefepime, and ampicillin until return of negative viral, fungal, and bacteria studies. He underwent mri brain and cervical spine with and without gadolinium, which demonstrated two extramedullary, non-enhancing, t1 hyperintense and t2 isointense, space-occupying masses in the left dorsal cervical spine at the c5 and c6 spinal cord levels. The masses resulted in moderate cord compression without cord signal change at both levels. The scs lead tip appeared to terminate at the level of the c5 mass and appeared subdural in location based on radiographic appearance but had the appearance of an epidural location caudal to this level. The appearance of the masses was believed to most likely represent subacute hematoma formation vs. Granulomatous reaction. The neurosurgery service was consulted, and he underwent c5¿7 posterior decompressive laminectomies for symptomatic cervical spinal cord compression from the masses. Intraoperatively, the scs lead was not visualized in the epidural space, and durotomy was performed to remove the lead from the surrounding thickened arachnoid tissue and adhesions. No cerebrospinal fluid, blood, or abscess was encountered. The ipg was also explanted. The final surgical pathology revealed fibrotic leptomeninges with chronic inflammation compatible with reactive changes; no granuloma, necrosis, or neoplasm was identified. The patient had gradual improvement of his head and neck pain over the course of seven days while hospitalized, and he was subsequently discharged to a skilled nursing facility for rehabilitation of his gait instability. The authors noted the patient¿s fibrotic leptomeninges were ¿likely the result of irritation from the scs lead. ¿ however, the authors added that leptomeningeal fibrosis had also previously been described following subarachnoid hemorrhage, which the patient had experienced twice in his past. The authors concluded that ¿it was possible that this may have contributed to the exaggerated development of fibrosis from the subdural scs location. ¿ no further complications were reported or anticipated.
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Manufacturer (Section D)
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key11497566
MDR Text Key240660562
Report Number2182207-2021-00461
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNEU_INS_STIMULATOR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/16/2021 Patient Sequence Number: 1