User's Manual

Safety Information
Precision Spectra™ System Information for Patients
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trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back
surgery syndrome, intractable low back and leg pain.
Effi cacy Evaluation
Three (3) clinical literature studies were used to support the effectiveness of the Precision Spectra™
System (Ohnmeiss et al. 1996, Villavincencio et al. 2000, Hassenbach SJ et al. 1995). The studies
included a total of 116 patients that were implanted with an SCS system. A total of approximately
3166 device months of experience was depicted from the retrospective clinical evaluation. All three
studies examined the effectiveness of SCS on patients with chronic pain of the trunk and/or limbs
including unilateral or bilateral pain associated with the following: failed back surgery syndrome or
intractable low back and leg pain. In all studies, a totally implantable spinal cord stimulator was used
in association with a percutaneous and/or surgical lead. These studies provide the same diagnostic
or therapeutic intervention for the same disease/conditions and patient population as the Precision
Spectra System.
The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of SCS in
patients with intractable leg pain. Forty patients were implanted with SCS systems and evaluated at
6 weeks, 12 months, and 24 months follow-up. Outcome measures included the VAS, pain drawings,
medication use, SIP (Sickness Impact Profi le), isometric lower extremity testing, and patient
questionnaires. An intent-to-treat analysis was performed. After patients had SCS for 24 months,