Precision™ Spinal Cord Stimulator System Clinician Manual
Clinician Manual
97035873-01 6 of 75
Table 1: Summary of Risks Identied 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 2 weeks to 6 months. The following major adverse events were reported.
Table 2: Clinical Experience Safety
Type Number of
Patients
Resolution
Lead Migration 1 Lead repositioning and subsequent replacement
Output malfunction 1 Device replaced
Infection 1 Infection treated
Pain 1 Lead explanted
Other minor adverse events reported by at least one patient included: receiver malfunction, skin irritation,
unpleasant stimulation, CSF leak, infection at implant site, lead migration, and OR cable malfunction. Two of
the subjects reported multiple events.
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