Patients should cautiously approach such devices and should request help to bypass them. 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. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. High stimulation outputs. The system is intended to be used with leads and associated extensions that are compatible with the system. 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 should be advised to not use therapeutic magnets. 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. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. Scuba diving or hyperbaric chambers. Keep dry to avoid damage. Damage to the system may not be immediately detectable. 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. Keep them dry to avoid damage. Component handling. 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. 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. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. radiofrequency identification (RFID) devices. separates the implanted IPGs to minimize unintended interaction with other system components. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. 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. If two systems are implanted, ensure that at least 20 cm (8 in.) 21 CR 801.109(b) The label of the device, other than surgical instruments, bears: (1) The symbol statement Rx only or only or the statement Caution: Federal law restricts this device to sale by or on the order of a ___, the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and. 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). separates the implanted generators to minimize unintended interaction with other system components. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Component disposal. The safety and efficacy of the implantation of greater than four leads have not been evaluated. 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. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Scanning under different conditions may cause device malfunction, severe patient injury, or death. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Equipment is not serviceable by the customer. away from the generator and avoid placing any smart device in a pocket near the generator. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Pediatric use. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Stimulation Modes. Use extreme care when handling system components. Infections related to system implantation might require that the device be explanted. Excessive lead migration may require reoperation to replace the leads. If interference occurs, try holding the phone to the other ear or turning off the phone. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Lead inspection. 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. 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. Battery precaution. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Patient activities and environmental precautions. During the implant procedure, if an electrosurgery device must be used, take the following actions:. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. IPG placement. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Lasting Relief through our smallest system yet. 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 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. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. 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 exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). 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. If unpleasant sensations occur, turn off stimulation immediately. 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. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. 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. Long-term safety and effectiveness. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Do not use the system if the use-before date has expired. Device modification. Back pain. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated. External defibrillators. Using the tunneling tool. Security, antitheft, and radiofrequency identification (RFID) devices. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Physicians should also discuss any risks of MRI with patients. Multiple leads. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Ensure the patients neurostimulation system is in MRI 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. Radiofrequency or microwave ablation. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS systems(available online atmedical.abbott/manuals). Electromagnetic interference (EMI). The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Thorough psychiatric screening should be performed. Unwanted changes in stimulation may include a jolting or shocking feeling. Conscious sedation. 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. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. If needed, return the equipment to Abbott Medical for service. Consumer goods and electronic devices. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. **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. 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. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Do not use surgical instruments to handle the lead. Follow proper infection control procedures. 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. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Coagulopathies. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. 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. Clinician training. 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. Confirm implant locations and scan requirements for the patients system. Read this section to gather important prescription and safety information. Pregnancy and nursing. Poor surgical risks. 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. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. 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. The following precautions apply to this neurostimulation system. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Patient training. 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. 737202011056 v5.0 | Item approved for U.S. use only. Do not crush, puncture, or burn these devices because explosion or fire may result. Damage to the system may not be immediately detectable. 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. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. 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. Infection. Sheath insertion warning. Case damage. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Activities requiring excessive twisting or stretching. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Electromagnetic interference (EMI). If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Bathing. Additional Disadvantages. Lead insertion through sheath. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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. Some of this systems electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Control of the patient controller. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Implantation of two systems. 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. 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. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. away from the generator and avoid placing any smart device in a pocket near the generator. 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. To prevent unintended stimulation, do not modify the generator software in any way. The Proclaim XR SCS system can provide relief to . Stimulation in unwanted places (such as radicular stimulation of the chest wall), Lead migration, causing changes in stimulation or reduced pain relief, Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant, Persistent pain at the electrode or generator site, Seroma (mass or swelling) at the generator site, Allergic or rejection response to implant materials, Implant migration or skin erosion around the implant. 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. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. 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. Electrosurgery. 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. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Charge density can be reduced by lowering the stimulation amplitude or pulse width. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. Mobile phones. 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. Diathermy is further prohibited because it may also damage the neurostimulation system components. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. 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. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. To prevent injury or damage to the system, do not modify the equipment. 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.**. 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). Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. 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 . Electromagnetic interference (EMI). High-output ultrasonics and lithotripsy. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Return all explanted generators to Abbott Medical for safe disposal. Use appropriate sterile technique when implanting leads and the IPG. Store components and their packaging where they will not come in contact with liquids of any kind. Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Return all explanted components to Abbott Medical for safe disposal. 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. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. Our Invisible Trial System TM is a discreet, app . Nerve damage may result from traumatic or surgical nerve injury. Household appliances. Implantation at vertebral levels above T10. This damage could result in loss of therapy, requiring additional surgery for system replacement. The following warnings apply to this neurostimulation system. Advance the needle and guidewire slowly. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Interference with other devices. Handle the programmers and controllers with care. Confirm the neurostimulation system is functioning. 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. Use caution when sedating the patient. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Always perform removal of implanted components with the patient conscious and able to give feedback. Securing the lead with the lead stabilizer will mitigate this risk. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. 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. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). Operation of machines, equipment, and vehicles. Explosive and flammable gasses. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. 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 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 . Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Neurosurgery Pain Management Orthopaedic Surgery All components listed must be implanted unless noted as "optional." Sheath retraction. Neurostimulation should not be used on patients who are poor surgical candidates. Explosive or flammable gasses. Storage environment. Consumer goods and electronic devices. 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. 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. This includes oxygen-enriched environments such as hyperbaric chambers.
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