Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Implantation of two systems. Lead insertion through sheath. Patients should avoid charging their generator over an incision that has not completely healed. 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. 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. Control of the patient controller. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Application modification. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). 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. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS 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. 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. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Object Info: - MRI Safety Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Do not crush, puncture, or burn these devices because explosion or fire may result. Ensure the patients neurostimulation system is in MRI mode. Failure to do so may result in difficulty delivering the lead. The following precautions apply to this neurostimulation system. Generators contain batteries as well as other potentially hazardous materials. Security, antitheft, and radiofrequency identification (RFID) devices. Damage to the system may not be immediately detectable. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Battery care. Skydiving, skiing, or hiking in the mountains. Infection. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Poor surgical risks. Patients should cautiously approach such devices and should request help to bypass them. Bending the sheath. Instructions for Use Website - SJM Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. To find Shipping Material Packaging Waste information, select Healthcare Professionals. To prevent injury or damage to the system, do not modify the equipment. Therapeutic magnets. Confirm the neurostimulation system is functioning correctly after the procedure. Component manipulation by patient. 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. FDA's expanded . 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. Stylet handling. 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. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Remove the stylet from the lead only when satisfied with lead placement. Consider seeking surgical advice if you cannot easily remove a lead. Lead movement. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Stimulation effectiveness. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Remove leads slowly (at a suggested rate of 1 cm/s while holding the lead between the thumb and forefinger) to avoid breaking the lead and leaving fragments in the patient. commercial electrical equipment (such as arc welders and induction furnaces). Do not crush, puncture, or burn the IPG because explosion or fire may result. 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, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. January 4, 2022 By Sean Whooley. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. ** Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Follow proper infection control procedures. External defibrillators. 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. Before reinserting the sheath, verify there is no damage to the sheath. Physicians should also discuss any risks of MRI with patients. The IPG should be explanted before cremation because the IPG could explode. separates the implanted generators to minimize unintended interaction with other system components. Patients should exercise reasonable caution when bathing. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Scuba diving or hyperbaric chambers. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. This equipment is not serviceable by the customer. Confirm implant locations and scan requirements for the patients system. 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,. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. 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. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. The system is intended to be used with leads and associated extensions that are compatible with the system. Advance the needle and guidewire slowly. 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. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Devices with one-hour recharge per day. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. 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. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Restricted areas. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. 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. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. Proclaim Plus: The Next Burst in Chronic Pain Care | Abbott Newsroom Neuromodulation | For Consumers | Abbott U.S. After defibrillation, confirm the neurostimulation system is still working. Patient activities and environmental precautions. Inserting the anchor. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 2013;16(5):471-482. 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. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Keep dry to avoid damage. Up to two leads, lead protection boots, and burr hole covers may be implanted. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. 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. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. If two systems are implanted, ensure that at least 20 cm (8 in.) Handle the programmers and controllers with care. The placement of the leads involves some risk, as with any surgical procedure. 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. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . 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. Bathing. Scuba diving and hyperbaric chambers. Lead handling. 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. Placement of lead connection in neck. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. The Proclaim XR SCS system can provide relief to . 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. Clinician programmers, patient controllers, and chargers are not waterproof. The system is intended to be used with leads and associated extensions that are compatible with the system. Overcommunicating with the IPG. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. Abbott - Spinal Cord Stimulation Read this section to gather important prescription and safety information. Providing strain relief. 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. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. An expiration date (or use-before date) is printed on the packaging. 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. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Confirm that no adverse conditions to MR scanning are present. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Use extreme care when handling system components. 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. PATIENTS Storage environment. Case damage. 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. 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. Product materials. Scuba diving or hyperbaric chambers. However, some patients may experience a decrease or increase in the perceived level of stimulation. Avoid placing equipment components directly over other electronic devices. 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. away from the generator and avoid placing any smart device in a pocket near the generator. Interference with wireless equipment. 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 be advised to not use therapeutic magnets. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Low frequencies. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Patient training. Exposure to body fluids or saline. 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. Infections may require that the device be explanted. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. 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). THE List - MRI Safety Coagulopathies. 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. Care and handling of components. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. When multiple leads are implanted, route the lead extensions so the area between them is minimized. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Package or component damage. Activities requiring coordination. Always perform removal with the patient conscious and able to give feedback. Therapeutic radiation. 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. Radiofrequency or microwave ablation. Consumer goods and electronic devices. Securing the anchor. radiofrequency identification (RFID) devices. This includes oxygen-enriched environments such as hyperbaric chambers. Keep the device dry. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. Avoid excessive stimulation. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Only apply software updates that are published directly by Abbott Medical. 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. Diathermy is further prohibited because it may also damage the neurostimulation system components. Proclaim XR SCS System Meaningful relief from chronic pain. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Scuba diving or hyperbaric chambers. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Pediatric use. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). 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. 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. High stimulation outputs. 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. Additional Disadvantages. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Care and handling of components. 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. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. 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. If multiple leads are implanted, leads and extensions should be routed in close proximity. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Wireless use restrictions. Do not use surgical instruments to handle the lead. Programmer and controller devices are not waterproof. 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. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. Infection. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Stimulation effectiveness has been established for one year. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. 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. Patient selection. Removing a kinked sheath. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. IMAGINE A FUTURE - cloud.neuroemail.abbott.com Safety Info ID# Safety Topic / Subject Article Text 294: Spinal Cord Stimulation Systems: St. Jude Medical: Genesis, GenesisXP, GenesisRC, Eon, Eon C, Eon Mini, and Renew The Genesis, GenesisXP, GenesisRC, Eon, EonC, Eon Mini, and Renew neuromodulation devices (St. Jude Medical) used for spinal cord stimul. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Loss of coordination is a potential side effect of DBS therapy. 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. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Do not use the system if the use-before date has expired. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. 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. 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. 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. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 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). Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. Case damage. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. Patients should cautiously approach such devices and should request help to bypass them. Have the patient check the device for proper functioning, even if the device was turned off.