Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Anchoring leads. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Device components. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Do not use the application if the operating system is compromised (that is, jailbroken). Pregnancy and nursing. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Expiration date. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). IMAGINE A FUTURE - cloud.neuroemail.abbott.com Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in a severe injury or death. If multiple leads are implanted, leads and extensions should be routed in close proximity. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. High stimulation outputs. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Why Proclaim XR SCS System - Abbott commercial electrical equipment (such as arc welders and induction furnaces). Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Patients should not use this neurostimulation system if they are pregnant or nursing. Control of the patient controller. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Operation of machines, equipment, and vehicles. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. 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. Operation of machines, equipment, and vehicles. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. Security, antitheft, and radiofrequency identification (RFID) devices. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. High-output ultrasonics and lithotripsy. Pregnancy and nursing. Conscious sedation. Patients who are unable to properly operate the system. Up to two leads, lead protection boots, and burr hole covers may be implanted. Schu S, Gulve A, ElDabe S, et al. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Lead movement. 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. Do not crush, puncture, or burn the generator because explosion or fire may result. The effect of mobile phones on deep brain stimulation is unknown. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Read this section to gather important prescription and safety information. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Damage to the system may not be immediately detectable. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Low frequencies. Do not crush, puncture, or burn the IPG because explosion or fire may result. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. 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. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. FDA's expanded . Electromagnetic interference (EMI). IPGs contain batteries as well as other potentially hazardous materials. If needed, return the equipment to Abbott Medical for service. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Multiple leads. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Back pain. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. Implantation of two systems. A recharge-by date is printed on the packaging. radiofrequency identification (RFID) devices. Application modification. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. Only apply software updates that are published directly by Abbott Medical. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. The placement of the leads involves some risk, as with any surgical procedure. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. If lithotripsy must be used, do not focus the energy near the IPG. Do not resterilize or reimplant an explanted system for any reason. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). Failure to do so may result in damage to the sheath. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. Thorough psychiatric screening should be performed. Changes in blood glucose levels in response to any adverse effect 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. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. The Proclaim XR SCS system can provide relief to . The following warnings apply to this neurostimulation system. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. The website that you have requested also may not be optimized for your screen size. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Lead inspection. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. 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, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in 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.