The force of the instruments may damage the lead or stylet. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Mobile phones. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers 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. If unpleasant sensations occur, the device should be turned off immediately. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. All components listed must be implanted unless noted as "optional." Free from the hassles of recharging. If needed, return the equipment to Abbott Medical for service. Set the electrosurgery device to the lowest possible energy setting. Device components. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. 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. The tip of the sheath may whip around and could cause harm to the patient. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). 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. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. External defibrillators. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. 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. 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. Generator disposal. 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. Diathermy therapy. 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. IPGs contain batteries as well as other potentially hazardous materials. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Component manipulation by patients. 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. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Securing the lead with the lead stabilizer will mitigate this risk. 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 . Product materials. If needed, return the equipment to Abbott Medical for service. Diathermy is further prohibited because it may also damage the neurostimulation system components. Expiration date. 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,. The device should be turned off and the doctor contacted if this occurs. Do not use excessive pressure when injecting through the sheath. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Electrosurgery. Computed tomography (CT). Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Spinal Cord Stimulator Systems - Boston Scientific 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. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. If needed, return the equipment to Abbott Medical for service. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Long-term safety and effectiveness. Device modification. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite. 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 cautiously approach such devices and should request help to bypass them. 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. 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. Lasting Relief through our smallest system yet. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Do not crush, puncture, or burn the generator because explosion or fire may result. Scuba diving or hyperbaric chambers. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. 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 Always perform removal of implanted components with the patient conscious and able to give feedback. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Wireless use restrictions. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) The following precautions apply to this neurostimulation system. Lead damage from tools. 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. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Scuba diving or hyperbaric chambers. six to eight weeks after implantation of a neurostimulation system. 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. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. 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. Schu S, Gulve A, ElDabe S, et al. 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Lead handling. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. 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. The Proclaim XR SCS system can provide relief to . Number of leads implanted. Removing each item in slow movements while holding the remaining components in place will assist this process. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. 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. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Clinician programmers, patient controllers, and chargers are not waterproof. 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. Use appropriate sterile technique when implanting leads and the IPG. 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. Electromagnetic interference (EMI). MRI Support | Abbott Neuromodulation If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Neurosurgery Pain Management Orthopaedic Surgery 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. 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. Bathing. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. Removing components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Why Proclaim XR SCS System - Abbott For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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 at medical.abbott/manuals). To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Advance the needle and guidewire slowly. Stimulation effectiveness. Lead inspection. 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. Programmer use. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. (2) The method of its application or use. Keep programmers and controllers dry. 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. Neuromodulation | For Consumers | Abbott U.S. Lead movement. Storage environment. Skydiving, skiing, or hiking in the mountains. Electromagnetic interference (EMI). 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. To prevent unintended stimulation, do not modify the operating system in any way. Getting an MRI | Medtronic Failure to provide strain relief may result in lead migration requiring a revision procedure. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Keep dry to avoid damage. Radiofrequency or microwave ablation. 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. Detailed information on storage environment is provided in the appendix of this manual. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. 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. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Do not crush, puncture, or burn the IPG because explosion or fire may result. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. 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. Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. However, some patients may experience a decrease or increase in the perceived level of stimulation. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Neuromodulation. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. 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. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Patients should cautiously approach such devices and should request help to bypass them. External defibrillators. Abbott's Proclaim XR Spinal Cord Stimulation System Now - Insider Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Stylet handling. Additionally, all patients will be awake and conversant during the procedure to minimize the impact.