Product Info

System Clinical Summary
WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers
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In this study, 7 (17%) patients suffered complications after implantation of the device; 5 (12%) patients
required repositioning of catheter type electrodes and 2 patients required revision of the stimulator
generator.
Safety Evaluation
Eleven studies were identied based on the detailed inclusion/exclusion criteria to demonstrate the
safety of the WaveWriter Alpha and WaveWriter Alpha Prime Systems. 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 IPG and RF
Systems. The clinical experience reported in the literature on RF systems is relevant to determining the
safety of totally implantable IPG systems.
Table 1: Summary of Risks Identi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.