New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation

Table 1

Neurological complications noted in the FDA MAUDE database according to device manufacturer and number of events reported.

Device Name	Adverse neurologic event	Number of events
Senza HF10 (Nevro)	New onset of migraine	1
	New onset panic attacks	1
	New onset of chest, flank, and leg pain	1
	New onset of headache, nausea, and vomiting	2
	Oral pain	1
	Rib pain	2
	Significant blood glucose fluctuations	1
	Inappropriate shocking sensations	3
	Shocking sensation at IPG site	4
Eon Mini (St. Jude)	Amplitude-dependent sensitivity around implant pocket	1
	Shocking sensation at IPG site	7
Protégé (St. Jude)	Increase in stimulation near registers and security sensors	1
	Uncontrolled limb movement while undergoing an MRI	1
	Shocking & tightness across the chest	1
Proclaim (St. Jude)	Overstimulation and discomfort at IPG site with stimulation	1