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. Select patients appropriately for deep brain stimulation. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. 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. Inaccurate ECG results may lead to inappropriate treatment of the patient. 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. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Pain is not resolved. 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. Operating the device near gas fumes or vapors could cause them to catch fire. Ultrasonic scanning equipment. The website that you have requested also may not be optimized for your screen size. The IPG should be explanted before cremation because the IPG could explode. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Package or component damage. Clinician training. Return all explanted generators to Abbott Medical for safe disposal. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Scuba diving or hyperbaric chambers. Do not use the system if the use-before date has expired. 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. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Component handling. 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. 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 should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. 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. Generator disposal. After defibrillation, confirm the neurostimulation system is still working. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Unwanted changes in stimulation may include a jolting or shocking feeling. Up to two leads, lead protection boots, and burr hole covers may be implanted. Thorough psychiatric screening should be performed. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Patient training. Damage to shallow implants. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. 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 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. Sheath rotation. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. This includes oxygen-enriched environments such as hyperbaric chambers. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. 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. Implantation of multiple leads. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. The system is intended to be used with leads and associated extensions that are compatible with the system. Stimulation Modes. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Schu S, Gulve A, ElDabe S, et al. 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,. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. 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. 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. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Return of symptoms and rebound effect. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Operation of machines, equipment, and vehicles. Lasting Relief through our smallest system yet. Therapeutic radiation. However, some patients may experience a decrease or increase in the perceived level of stimulation. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Changes in blood glucose levels in response to any adverse effect CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. 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. Set the electrosurgery device to the lowest possible energy setting. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Confirm implant locations and scan requirements for the patients system. Preventing infection. To prevent unintended stimulation, do not modify the operating system in any way. 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. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Confirm the neurostimulation system is functioning correctly after the procedure. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. To prevent unintended stimulation, do not modify the operating system in any way. 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. Loss of coordination is a potential side effect of DBS therapy. Diathermy is further prohibited because it may also damage the neurostimulation system components. Read this section to gather important prescription and safety information. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Component manipulation. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. This equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Component manipulation by patient. Component disposal. 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. 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. To prevent unintended stimulation, do not modify the generator software in any way. Patients should exercise reasonable caution when bathing. 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 placement of the leads involves some risk, as with any surgical procedure. Skydiving, skiing, or hiking in the mountains. 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. 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. Case damage. 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. Wireless use restrictions. Keep them dry to avoid damage. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. 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. After defibrillation, confirm the neurostimulation system is still working. Clinician training. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. communication equipment (such as microwave transmitters and high-power amateur transmitters). Damage to the system may not be immediately detectable. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Patients should cautiously approach such devices and should request help to bypass them. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Patients should cautiously approach such devices and should request help to bypass them. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. If multiple leads are implanted, leads and extensions should be routed in close proximity. Return the explanted IPG to Abbott Medical. 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. 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. Patient selection. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. 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. INDICATIONS FOR USE Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. 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.**. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). 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. Keep the device dry. six to eight weeks after implantation of a neurostimulation system. PATIENTS If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. 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. If needed, return the equipment to Abbott Medical for service. Care and handling of components. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Ensure the patients neurostimulation system is in MRI mode. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. 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. maximize the distance between the implanted systems; Use in patients with diabetes. Electromagnetic interference (EMI). Stimulation effectiveness. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. 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. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Clinician training. Excessive lead migration may require reoperation to replace the leads. Package or component damage. Lead movement. Do not suture directly onto the lead to avoid damaging the lead. 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. Return any suspect components to Abbott Medical for evaluation. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. 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). When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Stylet handling. commercial electrical equipment (such as arc welders and induction furnaces). We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Additional Disadvantages. 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. Pediatric use. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Before reinserting the sheath, verify there is no damage to the sheath. 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. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Security, antitheft, and radiofrequency identification (RFID) devices. ); 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. 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. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Detailed information on storage environment is provided in the appendix of this manual. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Inserting the anchor. Avoid placing equipment components directly over other electronic devices. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. 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. Electrical medical treatment. Damage to the system may not be immediately detectable. Damage to the system may not be immediately detectable. A recharge-by date is printed on the packaging. 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. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). 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. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. 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. Explosive or flammable gasses. Diathermy therapy. Radiofrequency or microwave ablation. Patient training. Security, antitheft, and radiofrequency identification (RFID) devices. Device components. **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. Patients should cautiously approach such devices and should request help to bypass them. Wireless use restrictions. radiofrequency identification (RFID) devices. Using the tunneling tool. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Storage environment. Confirm the neurostimulation system is functioning. Abandoned leads and replacement leads. Implant heating. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). 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. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Poor surgical risks. Return all explanted components to Abbott Medical for safe disposal. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. An expiration date (or use-before date) is printed on the packaging. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation.
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