For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. 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. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Long-term safety and effectiveness. Emergency procedures. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Operation of machines, equipment, and vehicles. Have the patient check the device for proper functioning, even if the device was turned off. Up to two leads, lead protection boots, and burr hole covers may be implanted. If needed, return the equipment to Abbott Medical for service. maximize the distance between the implanted systems; Use in patients with diabetes. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. 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). Keep them dry to avoid damage. 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 Security, antitheft, and radiofrequency identification (RFID) devices. Operation of machinery and equipment. Postural changes. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Do not use surgical instruments to handle the lead. Component disposal. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. 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. 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). Component manipulation by patients. Implantation at vertebral levels above T10. Make the Bold Choice Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. The following precautions apply to this neurostimulation system. The clinician programmer and patient controller are not waterproof. Keep them dry to avoid damage. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Care and handling of components. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Keep them dry to avoid damage. If two systems are implanted, ensure that at least 20 cm (8 in.) Battery care. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Read this section to gather important prescription and safety information. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Physicians should also discuss any risks of MRI with patients. 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). Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Place the neurostimulator in Surgery mode before using an electrosurgery device. Approved models and implant locations for an MR Conditional lead-only system. Operation of machines, equipment, and vehicles. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Use extreme care to not damage the lead with the sharp point of the tunneling tool. 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. Consider seeking surgical advice if you cannot easily remove a lead. Implantation of two systems. Explosive and flammable gasses. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. Component disposal. 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. 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. Patient selection. 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 neurostimulation system is contraindicated for patients who are. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. It is extremely important to select patients appropriately for neurostimulation. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. 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. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. IPG disposal. Patient's visual ability to read the patient controller screen. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. 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. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Patient training. Using the tunneling tool. Exit Surgery mode during intraoperative testing and after the procedure is completed. The equipment is not serviceable by the customer. External defibrillators. 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. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. For more information, see the clinician programmer manual. 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. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Electromagnetic interference (EMI). Storage environment. Clinician training. 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. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Coagulopathies. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Programmer and controller devices are not waterproof. Diathermy is further prohibited because it may also damage the neurostimulation system components. Package or component damage. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. 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. 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 the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Conscious sedation during removal. Electrosurgery. Stimulation effectiveness has been established for one year. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. 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. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Insertion of a sheath without the lead may result in dural puncture. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. If lithotripsy must be used, do not focus the energy near the generator. 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. Return the explanted IPG to Abbott Medical. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. 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. External defibrillators. If lithotripsy must be used, do not focus the energy near the IPG. Security, antitheft, and radiofrequency identification (RFID) devices. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Component handling. Handle the programmers and controllers with care. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Set the electrosurgery device to the lowest possible energy setting. six to eight weeks after implantation of a neurostimulation system. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. 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. Remove the stylet from the lead only when satisfied with lead placement. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). Nerve damage may result from traumatic or surgical nerve injury. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Generators contain batteries as well as other potentially hazardous materials. Use caution when sedating the patient. Removing a kinked sheath. Removing each item in slow movements while holding the remaining components in place will assist this process. 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. away from the generator and avoid placing any smart device in a pocket near the generator. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Product materials. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. 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). 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. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. 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.**. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. The placement of the leads involves some risk, as with any surgical procedure. Security, antitheft, and radiofrequency identification (RFID) devices. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Therapeutic magnets. The system is intended to be used with leads and associated extensions that are compatible with the system. Do not use excessive pressure when injecting through the sheath. Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur. 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. 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. 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. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Advise patients about adverse effects. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. separates the implanted IPGs to minimize unintended interaction with other system components. Neurosurgery Pain Management Orthopaedic Surgery Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Keep dry to avoid damage. 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. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. 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 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). Case damage. Securing the lead with the lead stabilizer will mitigate this risk. Placing the IPG. 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. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) 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. Loss of coordination is a potential side effect of DBS therapy. Keep programmers and controllers dry. Inaccurate ECG results may lead to inappropriate treatment of the patient. Do not crush, puncture, or burn the generator because explosion or fire may result. 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. Poor surgical risks. 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. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. 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. Skydiving, skiing, or hiking in the mountains. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Application modification. In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your generator immediately.). Stimulation effectiveness. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Before reinserting the sheath, verify there is no damage to the sheath. Skin erosion. Conscious sedation. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. Pediatric use. 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. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Stylet handling. Lasting Relief through our smallest system yet. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. If the patient requires a CT scan, all stimulation should be turned off before the procedure. 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). between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Storage environment. 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. This damage could result in loss of therapy, requiring additional surgery for system replacement. 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. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Return all explanted IPGs to Abbott Medical for safe disposal. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Electrosurgery. Scuba diving or hyperbaric chambers. Surgeon training. Return any suspect components to Abbott Medical for evaluation. Failure to provide strain relief may result in lead migration requiring a revision procedure. Transcutaneous electrical nerve stimulation (TENS). 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. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Poor surgical risks. 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. 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. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Radiofrequency or microwave ablation. Wireless use restrictions. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. If the stylet is removed from the lead, it may be difficult to reinsert it. 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). The following warnings apply to this neurostimulation system. Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Scuba diving and hyperbaric chambers. Interference with wireless equipment. 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. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Avoid placing equipment components directly over other electronic devices. If multiple leads are implanted, leads and extensions should be routed in close proximity. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. The Proclaim XR SCS system can provide relief to . Inserting the anchor. Do not use the application if the operating system is compromised (i.e., jailbroken). separates the implanted generators to minimize unintended interaction with other system components.