Skydiving, skiing, or hiking in the mountains. All components listed must be implanted unless noted as "optional." Back pain. Keep them dry to avoid damage. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. Battery precaution. Magnetic resonance imaging (MRI). Wireless use restrictions. 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. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. 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. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. 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. Physicians should also discuss any risks of MRI with patients. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Remove leads slowly. Patient selection. Care and handling of components. The IPG should be explanted before cremation because the IPG could explode. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. 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. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Component disposal. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. 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. Do not use the application if the operating system is compromised (that is, jailbroken). Use caution when sedating the patient. IPG disposal. 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). If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Stimulation effectiveness has been established for one year. Inserting the anchor. Scuba diving or hyperbaric chambers. Pediatric use. 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) for at least six weeks after implantation. Advance the needle and guidewire slowly. High stimulation outputs. Implantation of multiple leads. The following precautions apply to this neurostimulation system. Device modification. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Magnetic resonance imaging (MRI). Security, antitheft, and radiofrequency identification (RFID) devices. Store components and their packaging where they will not come in contact with liquids of any kind. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. 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. Removing components. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Electrosurgery. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Mobile phones. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. For more information, see the clinician programmer manual. Handle the programmers and controllers with care. Sheath insertion warning. 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. 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 the stylet is removed from the lead, it may be difficult to reinsert it. Patients should cautiously approach such devices and should request help to bypass them. Operating the device near gas fumes or vapors could cause them to catch fire. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Infections may require that the device be explanted. 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. Radiofrequency or microwave ablation. Transcutaneous electrical nerve stimulation (TENS). Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. 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. Excessive lead migration may require reoperation to replace the leads. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. Diathermy therapy. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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. Sheath rotation. Implantation of two systems. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Return all explanted components to Abbott Medical for safe disposal. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. The implanted components of this neurostimulation system are intended for a single use only. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. The safety and efficacy of the implantation of greater than four leads have not been evaluated. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. 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. Poor surgical risks. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. To prevent unintended stimulation, do not modify the generator software in any way. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 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. Application modification. Patients who are unable to properly operate the system. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) In rare cases, this can create a medical emergency. Clinician programmers, patient controllers, and chargers are not waterproof. 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. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. 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.