For more information, see the clinician programmer manual. 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. 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. Damage to shallow implants. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Electrocardiograms. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Have the patient check the device for proper functioning, even if the device was turned off. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Follow proper infection control procedures. Wireless use restrictions. Exposure to body fluids or saline. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Component disposal. IPG disposal. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. 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. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. For this reason, programming at frequencies less than 30 Hz is not recommended. Charge density can be reduced by lowering the stimulation amplitude or pulse width. 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). In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Number of leads implanted. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Select patients appropriately for deep brain stimulation. An expiration date (or use-before date) is printed on the packaging. IPGs contain batteries as well as other potentially hazardous materials. Consumer goods and electronic devices. However, some patients may experience a decrease or increase in the perceived level of stimulation. 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). PDF View Shellock R & D Services, Inc. email: . Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. 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. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. 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. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. 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. To prevent unintended stimulation, do not modify the operating system in any way. Coagulopathies. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. 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. External defibrillators. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Explosive or flammable gasses. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation 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. 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 multiple leads. 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. The equipment is not serviceable by the customer. 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. 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). However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Confirm that no adverse conditions to MR scanning are present. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Advance the needle and guidewire slowly. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. 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. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Do not use surgical instruments to handle the lead. Do not use excessive pressure when injecting through the sheath. Package or component damage. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Lasting Relief through our smallest system yet. After defibrillation, confirm the neurostimulation system is still working. Set the electrosurgery device to the lowest possible energy setting. 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. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Removing a kinked sheath. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Neuromodulation. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS systems(available online atmedical.abbott/manuals). When multiple leads are implanted, route the lead extensions so the area between them is minimized. If lithotripsy must be used, do not focus the energy near the IPG. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Bathing. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Patients should avoid charging their generator over an incision that has not completely healed. Electromagnetic interference (EMI). If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Using surgical instruments. Storage environment. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Securing the lead with the lead stabilizer will mitigate this risk. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . 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. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Clinician training. 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. The system is intended to be used with leads and associated extensions that are compatible with the system. Diathermy is further prohibited because it may also damage the neurostimulation system components. six to eight weeks after implantation of a neurostimulation system. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. If unpleasant sensations occur, the IPG should be turned off immediately. 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. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Conscious sedation during removal. Pregnancy and nursing. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. 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. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Patients should cautiously approach such devices and should request help to bypass them. Placement of lead connection in neck. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Up to two leads, lead protection boots, and burr hole covers may be implanted. 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. Patients should be advised to not use therapeutic magnets. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Implantation of multiple leads. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Diathermy is further prohibited because it may also damage the neurostimulation system components. Recharge-by date. Advise patients about adverse effects. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Component handling. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Clinician training. Storage environment. Loss of coordination is a potential side effect of DBS therapy. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Scuba diving and hyperbaric chambers. Return them to Abbott Medical for proper disposal. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Battery precaution. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Wireless use restrictions. away from the generator and avoid placing any smart device in a pocket near the generator. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. All components listed must be implanted unless noted as "optional." Inserting the anchor. During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. 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. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. 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. System testing. Emergency procedures. Patients should cautiously approach such devices and should request help to bypass them. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Patient training. The system is intended to be used with leads and associated extensions that are compatible with the system. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Device modification. All components listed must be implanted unless noted as "optional." Do not use the application if the operating system is compromised (that is, jailbroken). The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Some of this systems electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. Unwanted changes in stimulation may include a jolting or shocking feeling. Operating the device near gas fumes or vapors could cause them to catch fire. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Sheath insertion precaution. 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. Component manipulation. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. This neurostimulation system is contraindicated for patients who are. Keep them dry to avoid damage. Consumer goods and electronic devices. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. Battery care. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.).