Table 1.

Definitions and examples of complication categories.

Device-related complications
Migration	Migration of any lead from the original placement site
Erosion	Lead protruding through the skin
Lead damage	Breakage, fracture, kink, or other damage
Damage to sheath	Breakage, fracture, kink, or other damage
Lead connection failure	Loose connection or disconnection
Hardware malfunction	Battery failure, inoperable device, or IPG communication error
Difficult insertion	Difficulty with lead placement
Difficult removal	Difficulty with lead removal
Procedural complications
Neurologic symptoms	New or worsened neurologic symptoms which most commonly involve numbness, paresthesias, weakness, or pain not including musculoskeletal back pain at entry points*
Dural puncture	Visualized cerebrospinal fluid, suspected dural puncture, postdural puncture symptoms
Infection	Infectious symptoms associated with non-prophylactic treatment
Hematoma	Abnormal collection of blood
	Patient complaints
IPG site pain	Abnormal patient-reported discomfort at IPG site
Unwanted stimulation	Inappropriate or overstimulation, electrical shock-like sensations, or stimulation in an unwanted area
Surgically managed complications
Explant	Removal of all implanted components†
Revision	Removal of any implanted component
Serious adverse event	Epidural abscess, meningitis, seizure, asystole/cardiac arrest, stroke, death, neuraxial hematoma, admission to long-term rehabilitation, deep venous thrombosis, laminectomy/decompression surgery
Other	Events not included in the above definitions

^*Not including symptoms which were stimulation related and ceased upon decreasing or eliminating stimulation.

^†Removal of trials leads was not considered an explant.

IPG, implantable pulse generator.