Precision™ Spinal Cord Stimulator System Clinician Manual
Clinician Manual
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At the end of the crossover period, subjects were asked to choose between supra-perception and
subperception settings. Of the 70 subjects included in the primary effectivenss cohort, 53 subjects (76%)
chose subperception whereas only 17 (24%) chose supra-perception as their preferred treatment settings.
Additionally, 40 subjects (57%) preferred to keep both the stimulation treatments if given the option.
Safety Outcomes
A total of 27 adverse events were reported among 20 subjects across the entire study experience. Of the
27 adverse events, 12 were serious adverse events (SAEs) and 15 nonserious adverse events. All serious
adverse events were unrelated to the study-device and/or study-procedure. There were no unanticipated
events.
Contraindications
Patients contraindicated for permanent SCS therapy are those who:
• are unable to operate the SCS system
• have failed trial stimulation by failing to receive effective pain relief
• are poor surgical risks
• are pregnant
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