Low frequencies. Lead movement. 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. Device components. Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). 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. 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). Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. 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). Learn more about the scan details for our MR Conditional products below. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Diathermy is further prohibited because it may also damage the neurostimulation system components. If needed, return the equipment to Abbott Medical for service. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Package or component damage. Securing the IPG. 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 safety and efficacy of the implantation of greater than four leads have not been evaluated. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. Failure to do so may result in difficulty delivering the lead. Schu S, Gulve A, ElDabe S, et al. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. To prevent unintended stimulation, do not modify the operating system in any way. Case damage. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Damage to the system may not be immediately detectable. Place the neurostimulator in Surgery mode before using an electrosurgery device. radiofrequency identification (RFID) devices. Risk of depression, suicidal ideations, and suicide. 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. The system is intended to be used with leads and associated extensions that are compatible with the system. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used. This may occur once the lead is in place and is connected to the neurostimulator and activated. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 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. External defibrillators. Single-use, sterile device. Cremation. 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. Lasting Relief through our smallest system yet. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Lead insertion through sheath. High-output ultrasonics and lithotripsy. While charging the generator, patients may perceive an increase in temperature at the generator site. 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. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. If two systems are implanted, ensure that at least 20 cm (8 in.) away from the generator and avoid placing any smart device in a pocket near the generator. 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. 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. Return all explanted generators to Abbott Medical for safe disposal. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Component manipulation by patient. 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. Implantation of two systems. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Set the electrosurgery device to the lowest possible energy setting. Poor surgical risks. 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. 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. 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,. 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. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. Computed tomography (CT). Do not use the application if the operating system is compromised (that is, jailbroken). Unauthorized changes to stimulation parameters. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device. six to eight weeks after implantation of a neurostimulation system. Return the explanted IPG to Abbott Medical. Return any suspect components to Abbott Medical for evaluation. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. In rare cases, this can create a medical emergency. 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). The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. 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. Other active implantable devices. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Implantation at vertebral levels above T10. 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. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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. Free from the hassles of recharging. 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. 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. Advancing components. Operation of machines, equipment, and vehicles. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). Neurostimulation systems have materials that come in contact or may come in contact with tissue. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Security, antitheft, and radiofrequency identification (RFID) devices. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Care and handling of components. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Pediatric use. Restricted areas. 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. Using surgical instruments. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. After defibrillation, confirm the neurostimulation system is still working. Infection. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Bathing. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. 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. Product materials. Pregnancy and nursing. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Failure to do so can damage or cut the lead or sheath. 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 . 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. Removing each item in slow movements while holding the remaining components in place will assist this process. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. 2013;16(5):471-482. 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. Clinician programmers, patient controllers, and chargers are not waterproof. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Multiple leads. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Exposure to body fluids or saline. Patients should avoid charging their generator over an incision that has not completely healed. The following precautions apply to this neurostimulation system. Electromagnetic interference (EMI). Therapeutic radiation. Security, antitheft, and radiofrequency identification (RFID) devices. Exposure to body fluids or saline. away from the generator and avoid placing any smart device in a pocket near the generator. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Poor surgical risks. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. 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. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. 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. Coagulopathies. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. High-output ultrasonics and lithotripsy. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. 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. Long-term safety and effectiveness. Consider seeking surgical advice if you cannot easily remove a lead. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Household appliances. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Stimulation effectiveness. For more information, see the clinician programmer manual. 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. Physicians should also discuss any risks of MRI with patients. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. 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. The Proclaim XR SCS system can provide relief to . Return all explanted components to Abbott Medical for safe disposal. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). Clinician training. Patient training. 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 . These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. 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. The safety and effectiveness of neurostimulation for pediatric use have not been established. If unpleasant sensations occur, the device should be turned off immediately. Implant heating. Nerve damage may result from traumatic or surgical nerve injury. Clinician training. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Needle positioning. Care and handling of components. Pediatric use. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Output power below 80 W is recommended for all activations. To prevent injury or damage to the system, do not modify the equipment. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Wireless use restrictions. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Keep programmers and controllers dry. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Damage to the system may not be immediately detectable. Do not crush, puncture, or burn the generator because explosion or fire may result. 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 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 TMS or ECT in patients who have an implanted neurostimulation system. 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 use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Use extreme care when handling system components. Keep the device dry. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. High stimulation outputs and charge density limits. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Make the Bold Choice Component handling. Magnetic resonance imaging (MRI). For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. This neurostimulation system is contraindicated for patients who are. To prevent unintended stimulation, do not modify the operating system in any way. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. 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. 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. Have the patient check the device for proper functioning, even if the device was turned off. Providing strain relief. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. Return them to Abbott Medical for proper disposal. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Do not use surgical instruments to handle the lead. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Patient activities and environmental precautions. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted 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. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Abandoned leads and replacement leads. Our Invisible Trial System TM is a discreet, app . The placement of the leads involves some risk, as with any surgical procedure. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Implanting physicians should be experienced in stereotactic and functional neurosurgery. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Electromagnetic interference (EMI). Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Electrical medical treatment. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Implantation of two systems. Failure to do so may cause harm to the patient such as damage to the dura. The device should be turned off and the doctor contacted if this occurs. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Package or component damage. 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 Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Activities requiring coordination. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. 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. 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).
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