Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. To prevent injury or damage to the system, do not modify the equipment. 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. Only apply software updates that are published directly by Abbott Medical. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 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. Stimulation effectiveness. Implantation of two systems. Wireless use restrictions. 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. 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. 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. The force of the instruments may damage the lead or stylet. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. Application modification. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Patients who are unable to properly operate the system. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinsons disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. FDA's expanded . 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. January 4, 2022 By Sean Whooley. Diathermy therapy. Infections related to system implantation might require that the device be explanted. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Damage to the system may not be immediately detectable. Magnetic resonance imaging (MRI). Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Implantation at vertebral levels above T10. Up to two leads, lead protection boots, and burr hole covers may be implanted. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Damage to the system may not be immediately detectable. Component manipulation. Patients should cautiously approach such devices and should request help to bypass them. 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. 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. Clinician training. In rare cases, this can create a medical emergency. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. 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. Skydiving, skiing, or hiking in the mountains. Operation of machines, equipment, and vehicles. 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. Follow proper infection control procedures. 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. 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. See Full System Components below if the patient has an IPG and extensions implanted. Conscious sedation. 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. Electrical medical treatment. Explosive and flammable gasses. Component disposal. Advancing components. 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. Use extreme care when handling system components prior to implantation. Handle the device with care. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. All components listed must be implanted unless noted as "optional." Multiple leads. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Neurostimulation should not be used on patients who are poor surgical candidates. The system is intended to be used with leads and associated extensions that are compatible with the system. Detailed information on storage environment is provided in the appendix of this manual. Sheath rotation. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Control of the patient controller. The tip of the sheath may whip around and could cause harm to the patient. Do not crush, puncture, or burn the IPG because explosion or fire may result. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. *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. If the stylet is removed from the lead, it may be difficult to reinsert it. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Keep them dry to avoid damage. Use care when reinserting a stylet. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Cremation. Bending the sheath. 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). For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Risk of depression, suicidal ideations, and suicide. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. 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. Device modification. Insertion of a sheath without the lead may result in dural puncture. 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. Therapeutic radiation. 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. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Failure to do so may result in difficulty delivering the lead. 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. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Do not crush, puncture, or burn the generator because explosion or fire may result. Our Invisible Trial System TM is a discreet, app . Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Stimulation Modes. Consider seeking surgical advice if you cannot easily remove a lead. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Programmer use. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Do not crush, puncture, or burn these devices because explosion or fire may result. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). communication equipment (such as microwave transmitters and high-power amateur transmitters). Patient selection. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. Patients should not use this neurostimulation system if they are pregnant or nursing. 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 instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. Implantation of two systems. External defibrillators. Electromagnetic interference (EMI). Interference with wireless equipment. 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. IPGs contain batteries as well as other potentially hazardous materials. Neuromodulation. 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. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Patients should avoid charging their generator over an incision that has not completely healed. Operation of machines, equipment, and vehicles. Always perform removal with the patient conscious and able to give feedback. Scuba diving or hyperbaric chambers. Therapeutic radiation. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. After defibrillation, confirm the neurostimulation system is still working. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Keep dry to avoid damage. 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. An expiration date (or use-before date) is printed on the packaging. Wireless use restrictions. 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. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. Read this section to gather important prescription and safety information. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. 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. Patients should be advised to not use therapeutic magnets. INDICATIONS FOR USE Infection. 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. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Unauthorized changes to stimulation parameters. The following precautions apply to this neurostimulation system. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. The safety and efficacy of the implantation of greater than four leads have not been evaluated. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Skin erosion. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Mobile phones. Set the electrosurgery device to the lowest possible energy setting. Package or component damage. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Infection. Use extreme care to not damage the lead with the sharp point of the tunneling tool. 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Patient activities and environmental precautions. Thorough psychiatric screening should be performed. Additional Disadvantages. Return all explanted components to Abbott Medical for safe disposal. Patients should cautiously approach such devices and should request help to bypass them. Therapeutic magnets. Handle the programmers and controllers with care. Confirm that no adverse conditions to MR scanning are present. 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. 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. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. Free from the hassles of recharging. Needle positioning. If the programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. Return all explanted generators to Abbott Medical for safe disposal. To prevent unintended stimulation, do not modify the operating system in any way. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Damage to the system may not be immediately detectable. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. The effect of mobile phones on deep brain stimulation is unknown. 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. 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. Inserting the anchor. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. (2) The method of its application or use. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Avoid programming either device in a unipolar mode (using the devices can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. High stimulation outputs. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Infections related to system implantation might require that the device be explanted. 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. The website that you have requested also may not be optimized for your screen size. 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. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. 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. 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. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Learn more about the scan details for our MR Conditional products below. Equipment is not serviceable by the customer. Follow proper infection control procedures. 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Clinician training. While charging the generator, patients may perceive an increase in temperature at the generator site. Infection. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. If lithotripsy must be used, do not focus the energy near the generator. Lead inspection. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. 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.**. 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. Removing each item in slow movements while holding the remaining components in place will assist this process. 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 and induce voltage through the lead that could jolt or shock the patient. 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 system is intended to be used with leads and associated extensions that are compatible with the system. 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 multiple leads are implanted, leads and extensions should be routed in close proximity. 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.