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. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. 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. Component disposal. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. 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. If two systems are implanted, ensure that at least 20 cm (8 in.) Diathermy is further prohibited because it may also damage the neurostimulation system components. 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. 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. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Damage to the system may not be immediately detectable. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. 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. away from the generator and avoid placing any smart device in a pocket near the generator. The system is intended to be used with leads and associated extensions that are compatible with the system. Mobile phones. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Return all explanted generators to Abbott Medical for safe disposal. Bathing. Avoid placing equipment components directly over other electronic devices. Neuromodulation. 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. Always be aware of the needle tip position. Lasting Relief through our smallest system yet. 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 A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. 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. Sheath rotation. 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. Electromagnetic interference (EMI). 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. 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. 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. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Read this section to gather important prescription and safety information. Emergency procedures. Exposure to body fluids or saline. Return all explanted IPGs to Abbott Medical for safe disposal. The effect of mobile phones on deep brain stimulation is unknown. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 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. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Implantation of multiple leads. Mobile phones. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. High stimulation outputs. Needle positioning. Control of the patient controller. 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. Case damage. Implanting physicians should be experienced in stereotactic and functional neurosurgery. 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. 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. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Security, antitheft, and radiofrequency identification (RFID) devices. 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. 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. Ultrasonic scanning equipment. Consumer goods and electronic devices. Failure to do so may result in damage to the sheath. Have the patient check the device for proper functioning, even if the device was turned off. 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). For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. The safety and effectiveness of neurostimulation for pediatric use have not been established. Damage to the system may not be immediately detectable. Physicians should also discuss any risks of MRI with patients. 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. 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. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Magnetic resonance imaging (MRI). When multiple leads are implanted, route the lead extensions so the area between them is minimized. Risk of depression, suicidal ideations, and suicide. Learn more about the scan details for our MR Conditional products below. To prevent unintended stimulation, do not modify the operating system in any way. 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. Safety Info ID# Safety Topic / Subject Article Text 294: Spinal Cord Stimulation Systems: St. Jude Medical: Genesis, GenesisXP, GenesisRC, Eon, Eon C, Eon Mini, and Renew The Genesis, GenesisXP, GenesisRC, Eon, EonC, Eon Mini, and Renew neuromodulation devices (St. Jude Medical) used for spinal cord stimul. Handle the programmers and controllers with care. 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. Surgeon training. Do not suture directly onto the lead to avoid damaging the lead. Application 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). 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). Clinician training. FDA's expanded . These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. 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. Inaccurate ECG results may lead to inappropriate treatment of the patient. Patients should be advised to not use therapeutic magnets. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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. 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. Battery precaution. 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. Operation of machinery and equipment. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. IPGs contain batteries as well as other potentially hazardous materials. Neurostimulation should not be used on patients who are poor surgical candidates. Patients should cautiously approach such devices and should request help to bypass them. To prevent injury or damage to the system, do not modify the equipment. Transcutaneous electrical nerve stimulation (TENS). Physicians should also discuss any risks of MRI with patients. Keep them dry to avoid damage. Return of symptoms and rebound effect. Storage environment. Sheath retraction. 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. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. All components listed must be implanted unless noted as "optional." Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. 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,. Diathermy is further prohibited because it may also damage the neurostimulation system components. Ensure the patients neurostimulation system is in MRI mode. 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. High-output ultrasonics and lithotripsy. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Single-use, sterile device. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. 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. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Pregnancy and nursing. 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. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Expiration date. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Generator disposal. 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. In rare cases, this can create a medical emergency. Damage to shallow implants. Follow proper infection control procedures. Interference with other devices. Removing a kinked sheath. Thorough psychiatric screening should be performed. Component manipulation. Scuba diving or hyperbaric chambers. (2) The method of its application or use. 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. Advise patients about adverse effects. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. 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. 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. Explosive or flammable gasses. Case damage. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Multiple leads. radiofrequency identification (RFID) devices. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Implanted cardiac systems. Do not crush, puncture, or burn the IPG because explosion or fire may result. The tip of the sheath may whip around and could cause harm to the patient. INDICATIONS FOR USE Component manipulation by patients. 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. communication equipment (such as microwave transmitters and high-power amateur transmitters). Patients should cautiously approach such devices and should request help to bypass them. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. 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 avoid charging their generator over an incision that has not completely healed. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation 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. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinsons disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI. Securing the IPG. Electrocardiograms. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. 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), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). 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. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. 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. This may occur once the lead is in place and is connected to the neurostimulator and activated. Return all explanted components to Abbott Medical for safe disposal. 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.
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