Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Operation of machines, equipment, and vehicles. Transcutaneous electrical nerve stimulation (TENS). After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. With the Proclaim XR SCS system, you can have hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings* without ever needing to charge the system. Radiofrequency or microwave ablation. Infections related to system implantation might require that the device be explanted. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) IPG disposal. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. Instructions for Use Website - SJM Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Wireless use restrictions. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. Always be aware of the needle tip position. This neurostimulation system is indicated 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. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S. - New U.S. FDA-approved labeling lifts restrictions on 60-centimeter Octrode leads,. However, some patients may experience a decrease or increase in the perceived level of stimulation. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Approved models and implant locations for an MR Conditional lead-only system. Component disposal. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Lead damage from tools. Make the Bold Choice To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Consider seeking surgical advice if you cannot easily remove a lead. Implanted cardiac systems. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Device profile of the Proclaim XR neurostimulation system for the Electromagnetic interference (EMI). Use care when reinserting a stylet. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. six to eight weeks after implantation of a neurostimulation system. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Battery care. Scuba diving or hyperbaric chambers. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Implantation of two systems. Follow proper infection control procedures. Implantation of multiple leads. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. Diathermy is further prohibited because it may also damage the neurostimulation system components. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. For more information, see the clinician programmer manual. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. (2) The method of its application or use. Electromagnetic interference (EMI). Removing components. If lithotripsy must be used, do not focus the energy near the IPG. Inserting the anchor. To prevent unintended stimulation, do not modify the operating system in any way. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. High-output ultrasonics and lithotripsy. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Charge density can be reduced by lowering the stimulation amplitude or pulse width. Excessive lead migration may require reoperation to replace the leads. If the stylet is removed from the lead, it may be difficult to reinsert it. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Removing each item in slow movements while holding the remaining components in place will assist this process. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). FDA's expanded . Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Patient's visual ability to read the patient controller screen. The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 Damage to shallow implants. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Lead handling. Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Infection. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite. Scuba diving and hyperbaric chambers. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Before reinserting the sheath, verify there is no damage to the sheath. Battery precaution. Failure to do so may cause harm to the patient such as damage to the dura. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. Device modification. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation. Lead movement. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient. Case damage. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Learn more about the scan details for our MR Conditional products below. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app.
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