User's Manual

Device and Product Description
Precision Spectra™ System Information for Prescribers
90668515-01 Rev A 1 of 15
Device and Product Description
The Precision Spectra™ Spinal Cord Stimulation System consists of an Implantable Pulse
Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads,
Lead Extensions, OR Cables, Trial Stimulator, Remote Control, Clinician Programmer, and
Programming Wand, each packaged as a separate kit. Single use accessories and disposable
tools are also included in these kits.
Features of the Precision Spectra System include:
• Stimulation electrode fi eld navigation
• Thirty-two independent current-controlled electrodes
• Four programmable stimulation areas per program; sixteen possible programs
• Long-life operation
• High-range parameter capability
• Small size
• Two-foot programming range
• This product contains no detectable latex
Precision Spectra System Clinical Summary
Determination of the safety and effectiveness of the Precision Spectra System was based on
available published clinical studies for similar implanted spinal cord stimulation systems. The
Precision Spectra System is similar to the SCS systems reported in published literature in
intended use, target patient population, technology, device design, and output characteristics.
Therefore, the clinical data from the published literature described below represents evidence
supporting the safety and effectiveness of the Precision Spectra System for the treatment
chronic intractable pain of the 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.