The device should be turned off and the doctor contacted if this occurs. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. six to eight weeks after implantation of a neurostimulation system. Stimulation effectiveness has been established for one year. 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. Poor surgical risks. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Diathermy is further prohibited because it may also damage the neurostimulation system components. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. 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. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. However, some patients may experience a decrease or increase in the perceived level of stimulation. Detailed information on storage environment is provided in the appendix of this manual. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. The safety and effectiveness of neurostimulation for pediatric use have not been established. Only apply software updates that are published directly by Abbott Medical. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. Scuba diving or hyperbaric chambers. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Confirm that no adverse conditions to MR scanning are present. Conditional 5. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Unauthorized changes to stimulation parameters. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. 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). commercial electrical equipment (such as arc welders and induction furnaces). 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. 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). For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Removing components. Placement of lead connection in neck. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Mobile phones. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Equipment is not serviceable by the customer. Explosive and flammable gasses. Activities requiring coordination. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Radiofrequency or microwave ablation. Interference with wireless equipment. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Use care when reinserting a stylet. The effect of mobile phones on deep brain stimulation is unknown. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. If unpleasant sensations occur, turn off stimulation immediately. 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. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. The clinician programmer and patient controller are not waterproof. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. 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. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Before reinserting the sheath, verify there is no damage to the sheath. 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. 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. Failure to do so may result in difficulty delivering the lead. Return all explanted generators to Abbott Medical for safe disposal. 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. Store components and their packaging where they will not come in contact with liquids of any kind. Device profile of the Proclaim XR neurostimulation system for the away from the generator and avoid placing any smart device in a pocket near the generator. Wireless use restrictions. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Keep them dry to avoid damage. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. 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. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. separates the implanted IPGs to minimize unintended interaction with other system components. Stimulation Modes. Clinician training. Infection. 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. Electromagnetic interference (EMI). 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. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Stimulation effectiveness. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. 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. 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. Implanting physicians should be experienced in stereotactic and functional neurosurgery. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Pregnancy and nursing. Follow proper infection control procedures. Patients should avoid charging their generator over an incision that has not completely healed. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Cremation. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Expiration date. The Proclaim XR SCS system can provide relief to . 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. 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. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. Single-use, sterile device. Placing the IPG. Magnetic resonance imaging (MRI). Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Keep dry to avoid damage. Conscious sedation. Abbott - Spinal Cord Stimulation In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Disadvantages and Risks of Spinal Cord Stimulation Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. The IPG should be explanted before cremation because the IPG could explode. 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. Patients who are unable to properly operate the system. The safety and efficacy of the implantation of greater than four leads have not been evaluated. 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. Device components. Back pain. Always perform removal with the patient conscious and able to give feedback. 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. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Devices with one-hour recharge per day. Interference with other devices. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. 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. This equipment is not serviceable by the customer. 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. Bold New Spinal Cord Stimulation - Proclaim XR SCS System Coagulopathies. The system is intended to be used with leads and associated extensions that are compatible with the system. 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. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers FDA approves new MRI compatibility for Abbott's Proclaim spinal cord 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 use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Other active implantable devices. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. 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. Implantation of multiple leads. While charging the generator, patients may perceive an increase in temperature at the generator site. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. 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. 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 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). Sheath insertion precaution. separates the implanted generators to minimize unintended interaction with other system components. Lead damage from tools. 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. Implantation of two systems. 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. Electromagnetic interference (EMI).

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