System Handbook

Patient System Handbook

Safety Evaluation

Eleven studies were identified based on the detailed inclusion/exclusion criteria to

demonstrate the safety of the PRECISION System. The studies included a total of 1056

patients that were trialed with SCS systems and 880 patients that received implants. The

table below depicts the number of patients, the number of events, and the percentage of

occurrences of each event compared to the total number of patients. It should be noted that

citations cover both Stimulator and RF systems. The clinical experience reported in the

literature on RF systems is relevant to determining the safety of totally implantable

Stimulator systems.

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%