Refer to the product IFU for comprehensive safety messages when handling the device. Precautions: Device malfunction, loss of therapy, and other adverse events including patient injury may occur if the device is not handled or operated properly as described in the IFU. The effects of an implanted Prospera SCS System on other neurostimulators are unknown. The Prospera SCS System may interfere with the operation of implanted pacemakers or ICDs. Warnings: The following may cause electromagnetic interference, adverse interactions, insufficient or excessive stimulation, damage and function loss of the system, and/or therapy failure: external defibrillation, transcutaneous electrical nerve stimulation (TENs), lithotripsy, RF ablation, hyperbaric oxygen therapy, electrocautery, diathermy therapy (including shortwave, microwave, and therapeutic ultrasound therapies), high-power ultrasound, radiation therapy, Magnetic Resonance Imaging (MRI) scan (refer to Prospera SCS System MRI Guidelines for the system’s MR conditional information), use of portable RF communication equipment near the SCS system, use of a non-BIOTRONIK-provided charger. Note that the safety and effectiveness of Prospera SCS system has not been established in pediatric patients or pregnant or nursing patients. Contraindications: Implantation of a spinal cord stimulator may be contraindicated in patients who are unable to operate the SCS system, or who have failed to receive effective pain relief during SCS trial stimulation, or who are poor candidates for surgery. Indications for Use: The Prospera™ Spinal Cord Stimulation (SCS) System is indicated as an aid in the management of chronic, intractable pain in the trunk and/or limbs, which may include unilateral or bilateral pain. Lake Oswego, OR July 2022.īrief Summary: Please reference the appropriate product Instructions for Use (IFU) for more information regarding indications, contraindications, warnings, precautions, and potential adverse events. ![]() Prospera Spinal Cord Stimulation System, MRI Guidelines Technical Manual. Poster presented at: 26th Annual North American Neuromodulation Society Meeting January 12-15, 2023 Las Vegas, NV. 3-month study results for an implantable SCS system with multiphase stimulation and remote device management. Russo M, Yu J, Mohabbati V, Amirdelfan K, Kapural L, Verrills P. Poster presented at: The International Neuropsychological Society Annual Meeting JBarcelona, Spain. Functional ultrasound reveals activation properties of clinical spinal cord stimulation therapy. Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial). The effect of spinal cord stimulation on pain medication reduction in intractable spine and limb pain: a systematic review of randomized controlled trials and meta-analysis. Pollard EM, Lamer TJ, Moeschler SM, et al. Effectiveness of spinal cord stimulation in chronic spinal pain: a systematic review. ![]() Grider JS, Manchikanti L, Carayannopoulos A, et al. Washington (DC): National Academies Press (US) 2011. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. This product support is not a replacement for the patient's responsibility to communicate any medical questions or concerns with the physician's office. BIOTRONIK Neuro does not provide health advice or clinical actions outside the scope of spinal cord stimulator proper usage. **Proactive Care: BIOTRONIK Neuro's remote support team may reach out to patients to ensure proper usage of the spinal cord stimulator based on remotely monitored data. It is not intended to be used for medical diagnosis or medical treatment. *Embrace One is a support platform intended to help manage a patient's experience with spinal cord stimulation.
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