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Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. 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. Needle positioning. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Proclaim XR SCS System Meaningful relief from chronic pain. 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 implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Care and handling of components. Remove leads slowly (at a suggested rate of 1 cm/s while holding the lead between the thumb and forefinger) to avoid breaking the lead and leaving fragments in the patient. 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. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. This damage could result in loss of therapy, requiring additional surgery for system replacement. 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. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. 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. 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. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. *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. Securing the IPG. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). 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. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. If unpleasant sensations occur, the device should be turned off immediately. Clinician programmers, patient controllers, and chargers are not waterproof. Implantation of multiple leads. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Pain is not resolved. The equipment is not serviceable by the customer. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). While charging the generator, patients may perceive an increase in temperature at the generator site. 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. 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. Stimulation in unwanted places (such as radicular stimulation of the chest wall), Lead migration, causing changes in stimulation or reduced pain relief, Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant, Persistent pain at the electrode or generator site, Seroma (mass or swelling) at the generator site, Allergic or rejection response to implant materials, Implant migration or skin erosion around the implant. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Therapeutic radiation. Diathermy is further prohibited because it may also damage the neurostimulation system components. Implantation of two systems. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Return any suspect components to Abbott Medical for evaluation. Interference with wireless equipment. 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. Wireless communications equipment, such as mobile and cordless phones and walkie-talkies, may interfere with the IPG if the equipment gets too close to the IPG. After defibrillation, confirm the neurostimulation system is still working. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Component manipulation by patient. Avoid excessive stimulation. 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. Keep them dry to avoid damage. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . 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. Advise patients about adverse effects. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. 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. A summary of the safety and clinical performance (SSCP) for these devices will be published at https://ec.europa.eu/tools/eudamed by the Notified Bodies in accordance with the requirements of EU MDR 2017/745 and associated timelines. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. 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. 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. away from the generator and avoid placing any smart device in a pocket near the generator. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. Failure to do so may result in damage to the sheath. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Risk of depression, suicidal ideations, and suicide. Application modification. Patient activities and environmental precautions. 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. Electrocardiograms. 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). 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. Ensure the patients neurostimulation system is in MRI mode. Implantation at vertebral levels above T10. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Physicians should also discuss any risks of MRI with patients. 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. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. This includes oxygen-enriched environments such as hyperbaric chambers. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Nerve damage may result from traumatic or surgical nerve injury. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Keep programmers and controllers dry. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. 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). Magnetic resonance imaging (MRI). If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Long-term safety and effectiveness. 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. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). 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. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. Sheath insertion precaution. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. 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 patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. ** If patients feel that the TENS device may be interfering with the neurostimulator, patients should discontinue using the TENS device until they talk with their physician. Component disposal. To prevent unintended stimulation, do not modify the generator software in any way. 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 use surgical instruments on the stylet, as this may damage it. 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. Number of leads implanted. Battery care. See Full System Components below if the patient has an IPG and extensions implanted. Activities requiring coordination. 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.