Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. External defibrillators. Implantation of two systems. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Infections related to system implantation might require that the device be explanted. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. All components listed must be implanted unless noted as "optional." We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. However, some patients may experience a decrease or increase in the perceived level of stimulation. If unpleasant sensations occur, the IPG should be turned off immediately. Patient training. Confirm the neurostimulation system is functioning correctly after the procedure. After defibrillation, confirm the neurostimulation system is still working. 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. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). IPG disposal. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. 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). IPG placement. The system is intended to be used with leads and associated extensions that are compatible with the system. 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. 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. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Safety and effectiveness of neurostimulation for pediatric use have not been established. Follow proper infection control procedures. The U.S. Food and Drug Administration (FDA) has approved Abbott 's request to expand the magnetic resonance imaging (MRI) compatibility with its Proclaim XR spinal cord stimulation system with . Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. The placement of the leads involves some risk, as with any surgical procedure. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Expiration date. Confirm implant locations and scan requirements for the patients system. Read this section to gather important prescription and safety information. Number of leads implanted. Emergency procedures. If the stylet is removed from the lead, it may be difficult to reinsert it. Do not use excessive pressure when injecting through the sheath. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. 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. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. The implanted components of this neurostimulation system are intended for a single use only. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, 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, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. The system is intended to be used with leads and associated extensions that are compatible with the system. Transcutaneous electrical nerve stimulation (TENS). Nerve damage may result from traumatic or surgical nerve injury. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Return all explanted components to Abbott Medical for safe disposal. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. 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. For this reason, programming at frequencies less than 30 Hz is not recommended. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Stimulation effectiveness has been established for one year. Care and handling of components. 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. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Security, antitheft, and radiofrequency identification (RFID) devices. Preventing infection. Component manipulation by patient. 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. six to eight weeks after implantation of a neurostimulation system. Magnetic resonance imaging (MRI). Abandoned leads and replacement leads. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. 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. Always be aware of the needle tip position. Single-use, sterile device. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Damage to shallow implants. Risk of depression, suicidal ideations, and suicide. Poor surgical risks. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. PATIENTS Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Failure to provide strain relief may result in lead migration requiring a revision procedure. Caution patients to not make unauthorized changes to physician-established stimulation parameters. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Bathing. Up to two leads, lead protection boots, and burr hole covers may be implanted. Storage environment. Skin erosion. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. 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. Electrosurgery. Security, antitheft, and radiofrequency identification (RFID) devices. Using surgical instruments. Postural changes. The tip of the sheath may whip around and could cause harm to the patient. separates the implanted generators to minimize unintended interaction with other system components. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. After defibrillation, confirm the neurostimulation system is still working. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Implantation of multiple leads. 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. Return them to Abbott Medical for proper disposal. It is extremely important to select patients appropriately for neurostimulation. This neurostimulation system is contraindicated for patients who are. Diathermy is further prohibited because it may also damage the neurostimulation system components. If two systems are implanted, ensure that at least 20 cm (8 in.) Output power below 80 W is recommended for all activations. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. 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. 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. Avoid placing equipment components directly over other electronic devices. Implanting physicians should be experienced in stereotactic and functional neurosurgery. If two systems are implanted, ensure that at least 20 cm (8 in.) Magnetic resonance imaging (MRI). Neurostimulation should not be used on patients who are poor surgical candidates. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Sheath rotation. Insertion of a sheath without the lead may result in dural puncture. Patients should cautiously approach such devices and should request help to bypass them. Approved models and implant locations for an MR Conditional lead-only system. Wireless use restrictions. Explosive and flammable gasses. 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. Using the tunneling tool. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. All components listed must be implanted unless noted as "optional." Electrosurgery. 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. Always perform removal with the patient conscious and able to give feedback. Recharge-by date. Stabilizing the lead during insertion. Excessive lead migration may require reoperation to replace the leads. 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. Inserting the anchor. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). FDA's expanded . Neuromodulation. Package or component damage. 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. 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 use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Product materials. Return any suspect components to Abbott Medical for evaluation. Lead insertion through sheath. Lead movement. Consumer goods and electronic devices. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. away from the generator and avoid placing any smart device in a pocket near the generator. Patients should exercise reasonable caution when bathing. 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. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Set the electrosurgery device to the lowest possible energy setting. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. For more information, see the clinician programmer manual. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Overcommunicating with the IPG. Patients should avoid charging their generator over an incision that has not completely healed. 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 lithotripsy must be used, do not focus the energy near the IPG. 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. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Wireless use restrictions. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. 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. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. 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. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Household appliances. To prevent injury or damage to the system, do not modify the equipment. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. 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. 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. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Implantation of two systems. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Infection. 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. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown.
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