Sheath rotation. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. 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. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return. 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. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Keep them dry to avoid damage. Stimulation effectiveness. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Component manipulation by patients. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Advancing components. Computed tomography (CT). Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) 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. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. FDA's expanded . 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 High-output ultrasonics and lithotripsy. Loss of coordination is a potential side effect of DBS therapy. Poor surgical risks. Do not crush, puncture, or burn the IPG because explosion or fire may result. To prevent injury or damage to the system, do not modify the equipment. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Learn more about the scan details for our MR Conditional products below. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. If the stylet is removed from the lead, it may be difficult to reinsert it. Scuba diving and hyperbaric chambers. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. 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). Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Consider seeking surgical advice if you cannot easily remove a lead. Failure to do so may cause harm to the patient such as damage to the dura. Case damage. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Do not use excessive pressure when injecting through the sheath. Implantation of two systems. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Storage environment. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Magnetic resonance imaging (MRI). Lead insertion through sheath. Infections related to system implantation might require that the device be explanted. 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. Lead damage from tools. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Magnetic resonance imaging (MRI). Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Using surgical instruments. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. This neurostimulation system is contraindicated for patients who are. Set the electrosurgery device to the lowest possible energy setting. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Implanting physicians should be experienced in stereotactic and functional neurosurgery. PDF View Shellock R & D Services, Inc. email: . 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. Device modification. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. six to eight weeks after implantation of a neurostimulation system. Electrosurgery. 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. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. 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. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Exposure to body fluids or saline. Keep them dry to avoid damage. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Return all explanted generators to Abbott Medical for safe disposal. Devices with one-hour recharge per day. 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. communication equipment (such as microwave transmitters and high-power amateur transmitters). Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Therapeutic radiation. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Wireless use restrictions. 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. Insertion of a sheath without the lead may result in dural puncture. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 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. Securing the IPG. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Physicians should also discuss any risks of MRI with patients. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Infections related to system implantation might require that the device be explanted. Component manipulation by patient. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Using the tunneling tool. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Patients should cautiously approach such devices and should request help to bypass them. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. 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. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Store components and their packaging where they will not come in contact with liquids of any kind. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Interference with wireless equipment. Return of symptoms and rebound effect. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. After defibrillation, confirm the neurostimulation system is still working. Therapeutic radiation. Remove leads slowly. Radiofrequency or microwave ablation. 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. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Pregnancy and nursing. Pain is not resolved. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. 2013;16(5):471-482. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Device components. 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. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Component handling. Damage to shallow implants. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. 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. Only apply software updates that are published directly by Abbott Medical. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Component disposal. Conditional 5. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Case damage. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Do not use surgical instruments to handle the lead. Case damage. 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. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). The system is intended to be used with leads and associated extensions that are compatible with the system. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Anchoring leads. 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. Care and handling of components. Number of leads implanted. Battery precaution. 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. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). However, some patients may experience a decrease or increase in the perceived level of stimulation. 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. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. This damage could result in loss of therapy, requiring additional surgery for system replacement. 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. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. External defibrillators. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. 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 . To prevent unintended stimulation, do not modify the operating system in any way. Generators contain batteries as well as other potentially hazardous materials. 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. 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. Conscious sedation. Operation of machines, equipment, and vehicles. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Excessive lead migration may require reoperation to replace the leads. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. 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). Remove the stylet from the lead only when satisfied with lead placement. Pediatric use. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. 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. Device modification. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. **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. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 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 will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. 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. Back pain. Always perform removal with the patient conscious and able to give feedback. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Implantation of two systems. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead.