For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. 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. Return any suspect components to Abbott Medical for evaluation. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Needle positioning. 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. Damage to shallow implants. **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. Remove the stylet from the lead only when satisfied with lead placement. communication equipment (such as microwave transmitters and high-power amateur transmitters). Remove leads slowly. 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. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. If they must go through a gate or doorway containing this type of device, patients should turn off their generator and proceed with caution, being sure to move through the device quickly. 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 website that you have requested also may not be optimized for your screen size. Therapeutic magnets. The effect of mobile phones on deep brain stimulation is unknown. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Patients should cautiously approach such devices and should request help to bypass them. Control of the patient controller. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Physicians should also discuss any risks of MRI with patients. After defibrillation, confirm the neurostimulation system is still working. Interference with other devices. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Transcutaneous electrical nerve stimulation (TENS). Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. 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. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. If lithotripsy must be used, do not focus the energy near the IPG. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Conscious sedation. Operation of machines, equipment, and vehicles. Devices with one-hour recharge per day. separates the implanted generators to minimize unintended interaction with other system components. Implantation of multiple leads. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Do not crush, puncture, or burn the generator because explosion or fire may result. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. Patients should cautiously approach such devices and should request help to bypass them. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Do not use the system if the use-before date has expired. Emergency procedures. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. This may occur once the lead is in place and is connected to the neurostimulator and activated. Lead movement. Excessive lead migration may require reoperation to replace the leads. 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. Handle the device with care. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Scuba diving or hyperbaric chambers. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. Follow proper infection control procedures. The clinician programmer and patient controller are not waterproof. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Do not suture directly onto the lead to avoid damaging the lead. Proclaim XR SCS System Meaningful relief from chronic pain. Infections may require that the device be explanted. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. While charging the generator, patients may perceive an increase in temperature at the generator site. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. If lithotripsy must be used, do not focus the energy near the IPG. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Thorough psychiatric screening should be performed. Case damage. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Learn more about the scan details for our MR Conditional products below. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. 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 at medical.abbott/manuals). However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Patients should be advised to not use therapeutic magnets. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. 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. Set the electrosurgery device to the lowest possible energy setting. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 737202011056 v5.0 | Item approved for U.S. use only. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Explosive or flammable gasses. Infection. separates the implanted IPGs to minimize unintended interaction with other system components. Poor surgical risks. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Consider seeking surgical advice if you cannot easily remove a lead. Device modification. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. 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. Component disposal. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. (2) The method of its application or use. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. 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. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. The U.S. Food and Drug Administration (FDA) has approved Abbott 's request to expand the magnetic resonance imaging (MRI) compatibility with its Proclaim XR spinal cord stimulation system with .