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Close the clinician programmer or patient controller application, and turn the clinician
programmer or patient controller off and on
Wait a few minutes and try connecting again
Do not operate other wireless devices (i.e., laptop, tablet, mobile phone, or cordless phone)
at the same time
NOTE: Wireless communications equipment, such as wireless home network devices, mobile
and cordless telephones, and tablets, can affect the device.
Appendix E: Safety and Effectiveness Studies
This section includes information that supports the clinical use of this neurostimulation system.
This neurostimulation system is similar in technology and intended use to the systems reported in
the following literature and clinical studies. Therefore, the literature and clinical studies represent
the safety and effectiveness of this neurostimulation system.
Clinical Summary for the Genesis™ (IPG) Neurostimulation System
for SCS
The safety and effectiveness of the Genesis™ (IPG) neurostimulation system was determined
based on available published clinical studies for similar totally implanted SCS systems. The IPG
device 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 Genesis (IPG) neurostimulation system for use as an aid in the management
of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain
associated with the following: failed back surgery syndrome and intractable low back and leg pain.
Efficacy Evaluation
Three clinical literature studies were used to assess the safety and effectiveness of the Genesis™
(IPG) neurostimulation system (Ohnmeiss et al. 1996, Villavicencio et al. 2000, Hassenbusch 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 considered in 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, an identified
totally implantable spinal cord stimulator was used in association with a quadripolar percutaneous
epidural lead or a quadripolar lead. These studies provide the same diagnostic or therapeutic
intervention for the same disease/conditions and patient population as the Genesis (IPG)
neurostimulation 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, isometric lower extremity testing, and patient questionnaires. An
intent to treat analysis was performed. After patients had SCS for 24 months, leg pain, pain when
walking, standing pain, pain’s effect on overall lifestyle, and the total analog scale scores were
significantly improved from baseline. In this study, SCS was effective in improving intractable leg
pain.