User's Manual

Information for Prescribers
Precision Spectra™ System Information for Prescribers
90668515-01 Rev A 4 of 15
Table 1: Summary of Risks Identifi ed 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 Stimulation,
Ineffective Pain Control
46 4.4% 5.2%
Intermittent Stimulation 0 0% 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%
Clinical Experience-Safety
Clinical data has been collected during a clinical study of the Precision System. As of January
15, 2004, 35 subjects were enrolled in the study at multiple sites and 26 subjects had a
successful trial stimulation period and were implanted with the Precision System. The follow-up
period for the 26 implanted patients ranged from two weeks to six months. The following major
adverse events were reported.