Application modification. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Infections may require that the device be explanted. 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. 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. Before reinserting the sheath, verify there is no damage to the sheath. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). All components listed must be implanted unless noted as "optional." Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. The Proclaim XR SCS system can provide relief to . Proclaim XR SCS System Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Select patients appropriately for deep brain stimulation. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. 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. Neuromodulation | For Consumers | Abbott U.S. Learn more about the scan details for our MR Conditional products below. 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. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Using surgical instruments. Return them to Abbott Medical for proper disposal. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. 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). 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. Changes in blood glucose levels in response to any adverse effect If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. 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. Store components and their packaging where they will not come in contact with liquids of any kind. Devices with one-hour recharge per day. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Use caution when sedating the patient. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). 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. Patient training. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in a severe injury or death. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. This includes oxygen-enriched environments such as hyperbaric chambers. Patients should cautiously approach such devices and should request help to bypass them. radiofrequency identification (RFID) devices. Do not crush, puncture, or burn these devices because explosion or fire may result. Wireless use restrictions. Free from the hassles of recharging. Electromagnetic interference (EMI). Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. 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. Proclaim Plus: The Next Burst in Chronic Pain Care | Abbott Newsroom 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. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Sheath retraction. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Care and handling of components. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. 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. 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. Removing a kinked sheath. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. 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. High-output ultrasonics and lithotripsy. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Device profile of the Proclaim XR neurostimulation system for the It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. six to eight weeks after implantation of a neurostimulation system. Return all explanted components to Abbott Medical for safe disposal. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. If the stylet is removed from the lead, it may be difficult to reinsert it. Component handling. Patient selection. Use care when reinserting a stylet. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Clinician programmers, patient controllers, and chargers are not waterproof. Security, antitheft, and radiofrequency identification (RFID) devices. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. IPG disposal. Wireless use restrictions. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. ** Operation of machines, equipment, and vehicles. While charging the generator, patients may perceive an increase in temperature at the generator site. Needle positioning. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. The Eterna SCS 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. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. 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. Damage to the system may not be immediately detectable. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. To prevent injury or damage to the system, do not modify the equipment. The safety and effectiveness of neurostimulation for pediatric use have not been established. 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. separates the implanted IPGs to minimize unintended interaction with other system components. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Disadvantages and Risks of Spinal Cord Stimulation Return any suspect components to Abbott Medical for evaluation. 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. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Emergency procedures. Always perform removal with the patient conscious and able to give feedback. Battery precaution. 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. When multiple leads are implanted, route the lead extensions so the area between them is minimized. The following precautions apply to this neurostimulation system. Patients should cautiously approach such devices and should request help to bypass them. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Implantation of multiple leads. Sheath insertion precaution. 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. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. The effect of mobile phones on deep brain stimulation is unknown. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. 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. Patients who are unable to properly operate the system. Restricted areas. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. 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), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). 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. 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. Pain is not resolved. 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. Bold New Spinal Cord Stimulation - Proclaim XR SCS System If needed, return the equipment to Abbott Medical for service. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. For this reason, programming at frequencies less than 30 Hz is not recommended. Do not crush, puncture, or burn the generator because explosion or fire may result. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system. Handle the device with care. January 4, 2022 By Sean Whooley. 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. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Schu S, Gulve A, ElDabe S, et al. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Computed tomography (CT). Wireless use restrictions. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system.
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