User Manual

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Introduction

7

Table 1: Summary of Risks Identified in the Retrospective

Clinical Studies

Risks

# Patients

With

Adverse

Event

Intent-to-

Treat Basis

N = 1056

Implanted

Patient

Basis

N = 880

Lead Migration 175 16.6% 19.9%

Infection 39 3.7% 4.4%

Epidural Hemorrhage 0 0% 0%

Seroma 0 0% 0%

Hematoma 1 0.1% 0.1%

Paralysis 0 0% 0%

CSF Leak 5 0.5% 0.6%

Over/Under Stimula-

tion, Ineffective Pain

Control

46 4.4% 5.2%

Intermittent Stimula-

tion

00%0%

Pain Over Implant 16 1.5% 1.8%

Allergic Reaction 6 0.6% 0.7%

Skin Erosion 0 0% 0%

Lead Breakage 35 3.3% 4.0%

Hardware Malfunction 22 2.1% 2.5%

Loose Connection 0 0% 0%

Battery Failure 2 0.2% 0.2%

Other 45 4.3% 5.1%