abbott proclaim spinal cord stimulator mri safety abbott proclaim spinal cord stimulator mri safety

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 following precautions apply to this neurostimulation system. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. This neurostimulation system is contraindicated for patients who are. High-output ultrasonics and lithotripsy. 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. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Before reinserting the sheath, verify there is no damage to the sheath. Multiple leads. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. 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. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. 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. Do not use excessive pressure when injecting through the sheath. 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. Do not use the application if the operating system is compromised (i.e., jailbroken). The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. 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. 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. Patient activities and environmental precautions. The system is intended to be used with leads and associated extensions that are compatible with the system. Have the patient check the device for proper functioning, even if the device was turned off. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. 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. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. The safety and effectiveness of neurostimulation for pediatric use have not been established. Component disposal. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. 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. away from the generator and avoid placing any smart device in a pocket near the generator. 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. 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. The website that you have requested also may not be optimized for your screen size. Lead movement. 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. Pain is not resolved. 737202011056 v5.0 | Item approved for U.S. use only. 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. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. 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. 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. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 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. six to eight weeks after implantation of a neurostimulation system. Do not resterilize or reimplant an explanted system for any reason. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. If needed, return the equipment to Abbott Medical for service. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Electrocardiograms. 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. 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. 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) *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. The Proclaim TM SCS System is also the first upgradeable and recharge-free spinal cord stimulation system capable of delivering both tonic stimulation and Abbott's proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. This includes oxygen-enriched environments such as hyperbaric chambers. Operation of machines, equipment, and vehicles. 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. Confirm the neurostimulation system is functioning correctly after the procedure. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Advance the needle and guidewire slowly. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Package or component damage. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. IPGs contain batteries as well as other potentially hazardous materials. Patients should cautiously approach such devices and should request help to bypass them. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your generator immediately.). For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Clinician training. 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. Clinician training. Keep them dry to avoid damage. Transcutaneous electrical nerve stimulation (TENS). Patient's visual ability to read the patient controller screen. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Confirm implant locations and scan requirements for the patients system. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. PATIENTS Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. 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. 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. Providing strain relief. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. 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. In rare cases, this can create a medical emergency. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. To prevent injury or damage to the system, do not modify the equipment. 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. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. If needed, return the equipment to Abbott Medical for service. Do not use the system if the use-before date has expired. 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. Mobile phones. Patient training. 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. Do not use the application if the operating system is compromised (that is, jailbroken). Electromagnetic interference (EMI). Additionally, all patients will be awake and conversant during the procedure to minimize the impact. 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. The system is intended to be used with leads and associated extensions that are compatible with the system. The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 Always perform removal of implanted components with the patient conscious and able to give feedback. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. High stimulation outputs. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Failure to provide strain relief may result in lead migration requiring a revision procedure. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. Application modification. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. 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. Consumer goods and electronic devices. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Keep programmers and controllers dry. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Abandoned leads and replacement leads. Confirm that no adverse conditions to MR scanning are present. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. If unpleasant sensations occur, turn off stimulation immediately. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Securing the anchor. 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. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . This damage could result in loss of therapy, requiring additional surgery for system replacement. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Security, antitheft, and radiofrequency identification (RFID) devices. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. While charging the generator, patients may perceive an increase in temperature at the generator 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. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Patient selection. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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). 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). 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. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. This equipment is not serviceable by the customer. 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. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Device modification. The device should be turned off and the doctor contacted if this occurs. Household appliances. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Return any suspect components to Abbott Medical for evaluation. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Component manipulation by patients. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Patients should cautiously approach such devices and should request help to bypass them. Advancing components. Patients should exercise reasonable caution when bathing. Pediatric use. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Explosive and flammable gasses. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Patients should avoid charging their generator over an incision that has not completely healed. Conscious sedation during removal. 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.