Adverse Events Associated With 10-kHz Dorsal Column Spinal Cord Stimulation

Abstract

Background: High-frequency (10-kHz) spinal cord stimulation (SCS) continues to be an emerging therapy in chronic pain management. The same complications that plagued earlier SCS systems may affect newer stimulation technologies, although there is limited data on the type of complications and surgical management of these complications. Objective: The aim of this study was to systematically examine real-world complications associated with 10-kHz SCS reported on the Manufacturer and User Facility Device Experience (MAUDE) database. Materials and Methods: The MAUDE database was queried for entries reported between January 1, 2016 and December 31, 2020. Entries were classified into procedural complications, device-related complications, patient complaints, surgically managed complications, serious adverse events, and/or other complications. Primary outcomes included type and frequency of complications, and surgical management of complications. Results: A total of 1651 entries were analyzed. Most entries were categorized as procedural complications (72.6%), followed by serious adverse events (10.5%), device-related complications (10.5%), and patient complaints (9.9%). Most complications were managed surgically with explant (50.9%) rather than revision (5.0%) or incision/drainage (6.6%). Of procedural complications, the most common entries included non-neuraxial infection (52.9%), new neurological symptoms (14.7%), and dural puncture (9.5%). Of device-related complications, the most common entries included lead damage (41.6%), erosion (18.5%), and difficult insertion (11.5%). Conclusion: This retrospective 5-year analysis of complications from10-kHz SCS provides a real-world assessment of safety data unique for this stimulation modality. This analysis may help inform future clinical decisions, lead to device enhancement and optimization, and improve mitigation of risks to provide safe and efficacious use of 10-kHz SCS.

The contralateral oblique fluoroscopic view is associated with a lower incidence of postdural puncture headache in patients undergoing percutaneous spinal cord stimulation

“…There may also be a false over‐reliance on loss of resistance techniques. Accidental dural puncture continues to remain a common procedural complication of SCS according to a recent analysis of the 5‐year database of the manufacturer and user facility device experience (MAUDE) database 24 …”

“…Accidental dural puncture continues to remain a common procedural complication of SCS according to a recent analysis of the 5-year database of the manufacturer and user facility device experience (MAUDE) database. 24 Furthermore, a survey analysis of practice parameters among practicing interventional pain physicians on dural puncture during SCS procedures identified that up to 28% abandon trials and 22% abandon permanent implants if the dura is accidentally breached. 25 While the majority of physicians in the presence of known accidental dural puncture would elect to proceed with either the trial or the permanent SCS, there is enough practice variation that demonstrates that the management of this complication is not so straightforward and would be better off avoided.…”

Spinal Cord Stimulation for Painful Diabetic Neuropathy

“…With this approach, the trial period can be extended to as long as 30 days because the absence of external wires reduces the risk of infection. 86 Because percutaneous electrodes are no longer needed, an SCS trial can be extended as long as necessary with the use of as many waveforms and settings needed to achieve success or demonstrate 98 failure of the system. A successfully implanted SCS can remain in place permanently after the trial, eliminating the need for its removal and for implantation of a new set of stimulator components: a pulse generator and new leads containing new electrodes.…”

“…The types and numbers of surgical procedures described in the database for procedural and devicerelated complications are presented in Figures 7 and 8, respectively. 98 A potential drawback to implanting an SCS for PDN is that the most stimulation is delivered to a specific level of the spinal cord. If a patient experiences progressive involvement of more dermatomes, then the stimulation might eventually not cover the entire symptomatic area.…”

“…84 D'Souza and colleagues stated that SCS should be offered to patients who have refractory PDN and fail to benefit from conservative options, such as optimization of glucose control and neuropathic analgesic medications, before strong opioids are prescribed. 2 Meanwhile, current evidence favors a shift away 98 from traditional SCS and toward paresthesia-free HF SCS 99 as first-line neuromodulation treatment 72,100 based on an accumulation of evidence showing better outcomes for HF SCS compared with traditional SCS [101][102][103] for many types of pain, including PDN.…”