Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Implantation of two systems. Long-term safety and effectiveness. Infections related to system implantation might require that the device be explanted. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. 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). Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Schu S, Gulve A, ElDabe S, et al. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Use extreme care to not damage the lead with the sharp point of the tunneling tool. 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. Component disposal. Patient training. Remove leads slowly. Use extreme care when handling system components. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Equipment is not serviceable by the customer. See Full System Components below if the patient has an IPG and extensions implanted. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Application modification. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Placement of lead connection in neck. Explosive or flammable gasses. If lithotripsy must be used, do not focus the energy near the IPG. 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. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). Care and handling of components. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. 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. Component manipulation by patients. 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. communication equipment (such as microwave transmitters and high-power amateur transmitters). This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. 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). Exit Surgery mode during intraoperative testing and after the procedure is completed. Wireless use restrictions. Stimulation effectiveness. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. The IPG should be explanted before cremation because the IPG could explode. With the Proclaim XR SCS system, you can have hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings* without ever needing to charge the system. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Pregnancy and nursing. Read this section to gather important prescription and safety information. Providing strain relief. 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. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Free from the hassles of recharging. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Securing the anchor. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Application modification. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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. Sheath retraction. 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. January 4, 2022 By Sean Whooley. away from the generator and avoid placing any smart device in a pocket near the generator. To prevent injury or damage to the system, do not modify the equipment. Patients should cautiously approach such devices and should request help to bypass them. Skin erosion. Loss of coordination is a potential side effect of DBS therapy. Securing the IPG. Needle insertion. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device. 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,. Scuba diving and hyperbaric chambers. Scuba diving or hyperbaric chambers. Preventing infection. 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. 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. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. Patients should cautiously approach such devices and should request help to bypass them. Multiple leads. Monitor the patients blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. 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. Consumer goods and electronic devices. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. IPG disposal. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. To prevent injury or damage to the system, do not modify the equipment. Surgeon training. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. 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. Follow proper infection control procedures. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. Changes in blood glucose levels in response to any adverse effect
Electrosurgery. Follow proper infection control procedures. Operation of machines, equipment, and vehicles. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. 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. 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. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. 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. Store components and their packaging where they will not come in contact with liquids of any kind. Mobile phones. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. Electrosurgery. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. The system is intended to be used with leads and associated extensions that are compatible with the system. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Do not crush, puncture, or burn these devices because explosion or fire may result. Placing the IPG. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. 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. Implantation of two systems. Overcommunicating with the IPG. Neuromodulation. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Thorough psychiatric screening should be performed. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage 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. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. To prevent injury or damage to the system, do not modify the equipment. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. For more information, see the clinician programmer manual. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Some of this systems electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Operating the device near gas fumes or vapors could cause them to catch fire. Removing each item in slow movements while holding the remaining components in place will assist this process. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Return any suspect components to Abbott Medical for evaluation. Infection. Device modification. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Abandoned leads and replacement leads. Physicians should also discuss any risks of MRI with patients. *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. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. This may occur once the lead is in place and is connected to the neurostimulator and activated. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. 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. Physicians should also discuss any risks of MRI with patients. 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. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Unwanted changes in stimulation may include a jolting or shocking feeling. Avoid excessive stimulation. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite. If needed, return the equipment to Abbott Medical for service. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Component manipulation by patient. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. 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. Avoid placing equipment components directly over other electronic devices. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Safety and effectiveness of neurostimulation for pediatric use have not been established. Failure to do so may result in damage to the sheath. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. 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. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. 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. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. For this reason, programming at frequencies less than 30 Hz is not recommended. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. 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. 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. If lithotripsy must be used, do not focus the energy near the generator. If needed, return the equipment to Abbott Medical for service. The following precautions apply to this neurostimulation system. Programmer use. Lead damage from tools. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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. Advance the needle and guidewire slowly. 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. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. six to eight weeks after implantation of a neurostimulation system. Battery precaution. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Radiofrequency or microwave ablation. Generator disposal. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. 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.