Case Reports in Anesthesiology / 2019 / Article / Tab 1

Case Report

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 NameAdverse neurologic eventNumber of events

Senza HF10 (Nevro)New onset of migraine1
New onset panic attacks1
New onset of chest, flank, and leg pain1
New onset of headache, nausea, and vomiting2
Oral pain1
Rib pain2
Significant blood glucose fluctuations1
Inappropriate shocking sensations3
Shocking sensation at IPG site4

Eon Mini (St. Jude)Amplitude-dependent sensitivity around implant pocket1
Shocking sensation at IPG site7

Protégé (St. Jude)Increase in stimulation near registers and security sensors1
Uncontrolled limb movement while undergoing an MRI1
Shocking & tightness across the chest1

Proclaim (St. Jude)Overstimulation and discomfort at IPG site with stimulation1

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