Abbott Proclaim 3660 Clinician Manual
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Contents
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29 Close the clinician programmer or patient controller application, and turn the clinicianprogrammer 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 timeNOTE: Wireless communications equipment, such as wireless home network devices, mobileand cordless telephones, and tablets, can affect the device.Appendix E: Safety and Effectiveness StudiesThis 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 inthe following literature and clinical studies. Therefore, the literature and clinical studies representthe safety and effectiveness of this neurostimulation system.Clinical Summary for the Genesis™ (IPG) Neurostimulation Systemfor SCSThe safety and effectiveness of the Genesis™ (IPG) neurostimulation system was determinedbased on available published clinical studies for similar totally implanted SCS systems. The IPGdevice is similar to the SCS systems reported in published literature in intended use, target patientpopulation, technology, device design, and output characteristics. Therefore, the clinical datafrom the published literature described below represents evidence supporting the safety andeffectiveness of the Genesis (IPG) neurostimulation system for use as an aid in the managementof chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral painassociated with the following: failed back surgery syndrome and intractable low back and leg pain.Efficacy EvaluationThree 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 SJet 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 retrospectiveclinical evaluation. All three studies examined the effectiveness of SCS on patients with chronicpain 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 identifiedtotally implantable spinal cord stimulator was used in association with a quadripolar percutaneousepidural lead or a quadripolar lead. These studies provide the same diagnostic or therapeuticintervention 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 inpatients with intractable leg pain. Forty patients were implanted with SCS systems and evaluatedat 6 weeks, 12 months, and 24 months follow-up. Outcome measures included the VAS, paindrawings, medication use, SIP, isometric lower extremity testing, and patient questionnaires. Anintent to treat analysis was performed. After patients had SCS for 24 months, leg pain, pain whenwalking, standing pain, pain’s effect on overall lifestyle, and the total analog scale scores weresignificantly improved from baseline. In this study, SCS was effective in improving intractable legpain. |
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