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FDA Expands MRI Compatibility With Spinal Stimulation for Pain While charging the generator, patients may perceive an increase in temperature at the generator site. 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. PDF View Shellock R & D Services, Inc. email: . IMAGINE A FUTURE - cloud.neuroemail.abbott.com 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.**. Devices with one-hour recharge per day. If lithotripsy must be used, do not focus the energy near the generator. 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. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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. Securing the anchor. 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. Stimulation effectiveness has been established for one year. The effect of mobile phones on deep brain stimulation is unknown. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. 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. 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. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Confirm the neurostimulation system is functioning. Care and handling of components. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). 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 . Object Info: - MRI Safety Sheath insertion warning. Clinician programmers, patient controllers, and chargers are not waterproof. MRI Support | Abbott Device modification. Radiofrequency or microwave ablation. FDA's expanded . Do not crush, puncture, or burn these devices because explosion or fire may result. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Lead damage from tools. 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). Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Unauthorized changes to stimulation parameters. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Place the neurostimulator in Surgery mode before using an electrosurgery device. 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. Approved models and implant locations for an MR Conditional lead-only system. 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. 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. Implantation of two systems. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. The clinician programmer and patient controller are not waterproof. If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. It is extremely important to select patients appropriately for neurostimulation. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. INDICATIONS FOR USE Store components and their packaging where they will not come in contact with liquids of any kind. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. 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. Consumer goods and electronic devices. Do not use surgical instruments to handle the lead. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). System testing. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Pregnancy and nursing. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Equipment is not serviceable by the customer. 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. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Preventing infection. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Restricted areas. Why Proclaim XR SCS System - Abbott If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. 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. 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). Consumer goods and electronic devices. Patients should cautiously approach such devices and should request help to bypass them. Patients should not use this neurostimulation system if they are pregnant or nursing. Follow proper infection control procedures. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Use extreme care when handling system components prior to implantation. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Surgical advice for removal. separates the implanted IPGs to minimize unintended interaction with other system components. Free from the hassles of recharging. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. To prevent unintended stimulation, do not modify the generator software in any way. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) 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. Stabilizing the lead during insertion. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Poor surgical risks. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Infection. Exposure to body fluids or saline. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Follow proper infection control procedures. 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). six to eight weeks after implantation of a neurostimulation system. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Skydiving, skiing, or hiking in the mountains. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. 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 XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . 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. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Device profile of the Proclaim XR neurostimulation system for the 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 this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. 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. PATIENTS Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. 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. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Clinician training. Implantation at vertebral levels above T10. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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. MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Patients should exercise reasonable caution when bathing. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. 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. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Explosive and flammable gasses. Electrocardiograms. Damage to the system may not be immediately detectable. Clinician training. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Operation of machines, equipment, and vehicles. Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . 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. 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. Neuromodulation. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Battery care. 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. commercial electrical equipment (such as arc welders and induction furnaces). When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Pediatric use. 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.