Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Do not crush, puncture, or burn the generator because explosion or fire may result. The system is intended to be used with leads and associated extensions that are compatible with the system. Coagulopathies. 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. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. If radiation therapy is required, the area over the implanted generator should be shielded with lead. To prevent unintended stimulation, do not modify the generator software in any way. Lead insertion through sheath. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. If the stylet is removed from the lead, it may be difficult to reinsert it. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. The system is intended to be used with leads and associated extensions that are compatible with the system. Magnetic resonance imaging (MRI). Proclaim XR SCS System Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. 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. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. 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. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. 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. If lithotripsy must be used, do not focus the energy near the IPG. Free from the hassles of recharging. Advance the needle and guidewire slowly. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Return them to Abbott Medical for proper disposal. Confirm the neurostimulation system is functioning correctly after the procedure. Remove leads slowly. Implantation of two systems. Ensure the patients neurostimulation system is in MRI mode. Exposure to body fluids or saline. Keep them dry to avoid damage. Return of symptoms and rebound effect. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. IPG disposal. Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. After defibrillation, confirm the neurostimulation system is still working. Emergency procedures. This may occur once the lead is in place and is connected to the neurostimulator and activated. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Other active implantable devices. Use extreme care when handling system components prior to implantation. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. THE List - MRI Safety External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Therapeutic radiation. communication equipment (such as microwave transmitters and high-power amateur transmitters). maximize the distance between the implanted systems; Use in patients with diabetes. Radiofrequency or microwave ablation. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. Do not crush, puncture, or burn these devices because explosion or fire may result. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers If unpleasant sensations occur, turn off stimulation immediately. Skydiving, skiing, or hiking in the mountains. During the implant procedure, if an electrosurgery device must be used, take the following actions:. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Device profile of the Proclaim XR neurostimulation system for the In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. The safety and effectiveness of neurostimulation for pediatric use have not been established. Implantation of multiple leads. Activities requiring excessive twisting or stretching. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. 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. While charging the generator, patients may perceive an increase in temperature at the generator site. High-output ultrasonics and lithotripsy. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Application modification. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Household appliances. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Patients should exercise reasonable caution when bathing. Keep them dry to avoid damage. 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. 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. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Therapeutic radiation. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. 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. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Unauthorized changes to stimulation parameters. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. 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. To prevent injury or damage to the system, do not modify the equipment. Patient selection. Nerve damage may result from traumatic or surgical nerve injury. See Full System Components below if the patient has an IPG and extensions implanted. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers radiofrequency identification (RFID) devices. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II. Do not crush, puncture, or burn the IPG because explosion or fire may result. ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. Have the patient check the device for proper functioning, even if the device was turned off. separates the implanted IPGs to minimize unintended interaction with other system components. Clinician training. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Read this section to gather important prescription and safety information. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Failure to do so may result in difficulty delivering the lead. The Proclaim XR SCS system can provide relief to . For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems(available online atmedical.abbott/manuals). Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. 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 diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. The implanted components of this neurostimulation system are intended for a single use only. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Abandoned leads and replacement leads. This damage could result in loss of therapy, requiring additional surgery for system replacement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site.