Clinician training. Damage to shallow implants. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. After defibrillation, confirm the neurostimulation system is still working. Failure to do so may cause harm to the patient such as damage to the dura. 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). These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. If interference occurs, try holding the phone to the other ear or turning off the phone. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Magnetic resonance imaging (MRI). Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Make the Bold Choice Do not crush, puncture, or burn the IPG because explosion or fire may result. For this reason, programming at frequencies less than 30 Hz is not recommended. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) 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. Have the patient check the device for proper functioning, even if the device was turned off. Consumer goods and electronic devices. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Lead handling. Therapeutic radiation. Using surgical instruments. Generators contain batteries as well as other potentially hazardous materials. Radiofrequency or microwave ablation. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. An expiration date (or use-before date) is printed on the packaging. Explosive and flammable gasses. Recharge-by date. Electrosurgery. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Keep them dry to avoid damage. Programmer and controller devices are not waterproof. Security, antitheft, and radiofrequency identification (RFID) devices. All components listed must be implanted unless noted as "optional." 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. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Inserting the anchor. The Proclaim XR SCS system can provide relief to . 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, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. 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. Electromagnetic interference (EMI). If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Proclaim XR SCS System Meaningful relief from chronic pain. Confirm that no adverse conditions to MR scanning are present. Electromagnetic interference (EMI). 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. Security, antitheft, and radiofrequency identification (RFID) devices. Remove the stylet from the lead only when satisfied with lead placement. 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. Single-use, sterile device. Lead movement. 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. 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. Damage to the system may not be immediately detectable. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. 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. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. 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. Do not use the application if the operating system is compromised (that is, jailbroken). FDA's expanded . Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. It is extremely important to select patients appropriately for neurostimulation. Sheath insertion precaution. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Failure to do so may result in damage to the sheath. 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. Lead movement. Sheath retraction. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system. Patient's visual ability to read the patient controller screen. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Operating the device near gas fumes or vapors could cause them to catch fire. 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. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. 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. Sheath insertion warning. 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. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. Postural changes. Product materials. The system is intended to be used with leads and associated extensions that are compatible with the system. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Neurostimulation should not be used on patients who are poor surgical candidates. Other active implantable devices. 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. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. If two systems are implanted, ensure that at least 20 cm (8 in.) If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. The device should be turned off and the doctor contacted if this occurs. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. communication equipment (such as microwave transmitters and high-power amateur transmitters). System testing. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated. 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). Mobile phones. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. commercial electrical equipment (such as arc welders and induction furnaces). Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. 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. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. Pregnancy and nursing. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Devices with one-hour recharge per day. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Bending the sheath. 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. 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. Conscious sedation. 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. Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Neuromodulation. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Needle insertion. Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. 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,. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Confirm implant locations and scan requirements for the patients system. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Battery care. 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. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. 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 unpleasant sensations occur, turn off stimulation immediately. 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. Neurosurgery Pain Management Orthopaedic Surgery 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. 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.