Minimal adverse effects profile following implantation of periauricular percutaneous electrical nerve field stimulators: a retrospective cohort study

Arthur Roberts, Alec Sithole, Marcos Sedghi, Charles A Walker, Theresa M Quinn, Arthur Roberts, Alec Sithole, Marcos Sedghi, Charles A Walker, Theresa M Quinn

Abstract

The periauricular percutaneous implantation of the Neuro-Stim System™ family of devices EAD, MFS, and BRIDGE is a procedure involving the use of a non-opiate, neuromodulation analgesic for relieving acute and chronic pain. It has been approved as a minimal-risk procedure by multiple governmental and institutional facilities. This retrospective report of findings will help quantify the incidence of clinically observed bleeding, localized dermatitis, and infections at the implantation sites of the electrode/needle arrays, dermatitis at the site of the generator, and patient syncope. A total of 1,207 devices, each producing up to 16 percutaneous punctures, for a total of 19,312 punctures were monitored for adverse effects, based on retrospective chart audits conducted at six clinical facilities over a 1-year period.

Keywords: Bridge; EAD; MFS; Neuro-Stim System™ devices; adverse effects; clinical risks and discomfort; neuromodulation; percutaneous auricular neurostimulation.

Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Concentration of cranial nerves. Abbreviations: LON, lesser occipital nerve; ABVN, auricular branch of vagus nerve; GAN, great auricular nerve; GON, greater occipital nerve.
Figure 2
Figure 2
Assembled Neuro-Stim System™ device.
Figure 3
Figure 3
Device convenience kit.
Figure 4
Figure 4
Neurovascular bundles isolated by transillumination.
Figure 5
Figure 5
Activated device properly implanted.

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