Radiofrequency or microwave ablation. 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. This neurostimulation system is contraindicated for patients who are. Patient selection. If unpleasant sensations occur, the IPG should be turned off immediately. Return all explanted generators to Abbott Medical for safe disposal. Do not use the application if the operating system is compromised (that is, jailbroken). 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. Battery care. 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. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Pregnancy and nursing. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. If 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. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. 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. Application modification. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. 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). The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Device modification. Needle insertion. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Product materials. Remove the stylet from the lead only when satisfied with lead placement. Keep them dry to avoid damage. All components listed must be implanted unless noted as "optional." Scuba diving or hyperbaric chambers. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. If the stylet is removed from the lead, it may be difficult to reinsert it. Device modification. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Lead movement. 2013;16(5):471-482. Therapeutic radiation. Generators contain batteries as well as other potentially hazardous materials. Safety and effectiveness of neurostimulation for pediatric use have not been established. Patients should cautiously approach such devices and should request help to bypass them. 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. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. However, some patients may experience a decrease or increase in the perceived level of stimulation. Device components. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. Poor surgical risks. 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 . Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Preventing infection. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Package or component damage. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. 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. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Always be aware of the needle tip position. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 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). Always perform removal with the patient conscious and able to give feedback. Pain is not resolved. The following warnings apply to this neurostimulation system. 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. 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. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Component manipulation. 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. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Skin erosion. Expiration date. This equipment is not serviceable by the customer. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Neurostimulation systems have materials that come in contact or may come in contact with tissue. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Component manipulation by patients. Conscious sedation. High stimulation outputs. 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. 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. Do not crush, puncture, or burn the IPG because explosion or fire may result. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. IPG disposal. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. 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). Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Patient's visual ability to read the patient controller screen. separates the implanted IPGs to minimize unintended interaction with other system components. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation. If interference occurs, try holding the phone to the other ear or turning off the phone. Other active implantable devices. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. IPGs contain batteries as well as other potentially hazardous materials. Patients should avoid charging their generator over an incision that has not completely healed. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. 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. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Device modification. Diathermy is further prohibited because it may also damage the neurostimulation system components. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. 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. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. *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. Patient selection. 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. 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. 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,. Wireless use restrictions. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Pregnancy and nursing. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Consumer goods and electronic devices. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Programmer and controller devices are not waterproof. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. 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). A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Long-term safety and effectiveness. 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. Application modification. Handle the programmers and controllers with care. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Make the Bold Choice Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Return all explanted IPGs to Abbott Medical for safe disposal. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. 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. Patient training. 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. 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 clinician programmer and patient controller are not waterproof. Component disposal. Clinician programmers, patient controllers, and chargers are not waterproof. Lead movement. Electrosurgery. High-output ultrasonics and lithotripsy. 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. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. 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. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. 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). 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Use extreme care to not damage the lead with the sharp point of the tunneling tool. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Clinician training. Number of leads implanted. 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. Implantation at vertebral levels above T10. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. If needed, return the equipment to Abbott Medical for service. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Return any suspect components to Abbott Medical for evaluation. Sheath rotation. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Magnetic resonance imaging (MRI). 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. Lead handling. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Coagulopathies. The website that you have requested also may not be optimized for your screen size. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. See Full System Components below if the patient has an IPG and extensions implanted. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. 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. 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 IPG should be explanted before cremation because the IPG could explode. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. 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. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Failure to provide strain relief may result in lead migration requiring a revision procedure. If lithotripsy must be used, do not focus the energy near the IPG. Avoid excessive stimulation. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Stabilizing the lead during insertion. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. Do not crush, puncture, or burn the generator because explosion or fire may result. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Implantation of two systems. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . 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). 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. Advance the needle and guidewire slowly. Mobile phones. 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. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. 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. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Clinician training. Sheath insertion warning. Use extreme care when handling system components. Detailed information on storage environment is provided in the appendix of this manual. For more information, see the clinician programmer manual. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. 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. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. After defibrillation, confirm the neurostimulation system is still working. Transcutaneous electrical nerve stimulation (TENS). For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. 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. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Return the explanted IPG to Abbott Medical. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Wireless use restrictions. 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. 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. 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. Infections related to system implantation might require that the device be explanted. Confirm that no adverse conditions to MR scanning are present. commercial electrical equipment (such as arc welders and induction furnaces). Always perform removal of implanted components with the patient conscious and able to give feedback. Consider seeking surgical advice if you cannot easily remove a lead. Our Invisible Trial System TM is a discreet, app . During the implant procedure, if an electrosurgery device must be used, take the following actions:. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. For this reason, programming at frequencies less than 30 Hz is not recommended. 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.).