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Table 2 Reported rates of clinical consequences of implanted neural interface device failure. References: (Branco et al. 2023; Chapman et al. 2024; da Cruz et al. 2016; Daschner et al. 2017; Deng et al. 2006; Eldabe et al. 2016; FDA 2023, 2020; Force and da Silva 2017; Garg and Wang 2023; Goudman et al. 2024; Hines et al. 2022; Hoffmann et al. 2023; Horan et al. 2020; Ilfeld et al. 2017; Kahlow and Olivecrona 2013; Lander et al. 2020; Meng et al. 2018; Mitchell et al. 2023; Moman et al. 2021; Morishita et al. 2017; Mostafa and El Fiky 2024; Olson et al. 2023; Orlando and Cruz 2024; Pepper et al. 2013; Rizzo et al. 2020; Rolston et al. 2016; Rueb et al. 2020; Shibata et al. 2015; Sivanesan et al. 2019; Spindler et al. 2023; Toffa et al. 2020; Triolo et al. 2018; Vanloon et al. 2025; White-Dzuro et al. 2016)

From: Overcoming failure: improving acceptance and success of implanted neural interfaces

Name

Complication(s) and Rate(s)

Deep brain stimulation (DBS)

Hardware-related infections (4%); readjustment of lead position (2.7%); lead fracture (1.4%); lead migration (12.3%); pneunomia (2.3%); hematoma (1.4%); intracranial bleeding (6.1%); pulmonary embolism (0.6%); death (0.2–0.32%)

Electrocorticography (ECoG)

Surgical site infection (4%); hematoma (1–7.3%); infection from subdural placement (2.4–15.6%); seizure (1–41%); deep vein thrombosis (2.3%); sepsis (< 1%); death (< 1%)

Depth electrodes

Surgical site infection (2.4–14.9%)

Stentrode endovascular electrode array

Hematoma at insertion site (1/4 participants)

Spinal cord stimulation (SCS)

Lead migration (3.07–9.97%); lead explant (2.02%); implanted pulse generator explant (2.67%); infection (3.4–10%); hematoma (0.81%); device malfunction (27.1%); spinal cord injury (0.42%); death (0.47%)

Dorsal root ganglion stimulation (DRGS)

Trial lead infection (1,03%); implant infection (4.8%); revision infection (3.85%); lead migration (0.7–9.1%); lead fracture (6%); lead migration (6%); lead defects (39%); revision (29%); fragments left following lead removal (12%); explant (12%); permanent nerve damage during replacement procedure (9.1%)

Cochlear implant

Surgical site infection (1.4–3.2%); hematoma or seroma (1.3–2.6%); major infection and necrosis (2.3%); device fault (0.5%); electrode extrusion (2.6%); permanent facial palsy (0.09%)

Retinal prosthesis

Revision surgery (3.4%); conjunctival erosion (6.2%); retinal detachment (6.7%); infection (16.7%)

Vagus nerve stimulation

Surgical site infection (2.6–3.5%); hematoma (1.9%); lead fracture (3–11.9%); lead disconnection (0.2–2.5%); stimulator malfunction (1.4%); battery displacement (0.2%); persistent vocal cord palsy (0.7%); deep infection requiring explant (3.5%); explant due to implanted pulse generator dysfunction (4–16.8%)

Peripheral nerve stimulation

Infection (0.1–0.7%); electrode failure (2–10%); lead fracture (6.25%)

Sacral stimulation

Infection (1.6–6.6%); seroma or hematoma (3%); pocket revision due to infection (14.6%); lead wire breakage (7.5%); lead fragments left behind following breakage (6%); lead migration (2.1%); battery depletion requiring reoperation (1.7–39%); lead revision (13–18%); explant (4–24%)