Patient's visual ability to read the patient controller screen. 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. Package or component damage. However, some patients may experience a decrease or increase in the perceived level of stimulation. Sheath rotation. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. 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. Electrocardiograms. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. away from the generator and avoid placing any smart device in a pocket near the generator. 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. To prevent injury or damage to the system, do not modify the equipment. The Proclaim XR SCS system can provide relief to . Package or component damage. 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. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. To prevent injury or damage to the system, do not modify the equipment. 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. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Scuba diving or hyperbaric chambers. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Patients should cautiously approach such devices and should request help to bypass them. Always perform removal of implanted components with the patient conscious and able to give feedback. Security, antitheft, and radiofrequency identification (RFID) devices. The Eterna SCS System is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. Lead damage from tools. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Return any suspect components to Abbott Medical for evaluation. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. High stimulation outputs. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. 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. Confirm that no adverse conditions to MR scanning are present. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. 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. 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. Keep them dry to avoid damage. 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. Follow proper infection control procedures. Recharge-by date. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. The device should be turned off and the doctor contacted if this occurs. 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). After defibrillation, confirm the neurostimulation system is still working. 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. Neurostimulation should not be used on patients who are poor surgical candidates. Skydiving, skiing, or hiking in the mountains. If needed, return the equipment to Abbott Medical for service. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Operation of machinery and equipment. If lithotripsy must be used, do not focus the energy near the IPG. Return all explanted components to Abbott Medical for safe disposal. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Do not crush, puncture, or burn the IPG because explosion or fire may result. Patients should exercise reasonable caution when bathing. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Damage to the system may not be immediately detectable. Diathermy is further prohibited because it may also damage the neurostimulation system components. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. 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. 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. Security, antitheft, and radiofrequency identification (RFID) devices. Interference with other devices. Electrical medical treatment. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Back pain. Magnetic resonance imaging (MRI). While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Place the neurostimulator in Surgery mode before using an electrosurgery device. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Proclaim XR SCS System Meaningful relief from chronic pain. Needle insertion. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Do not use the system if the use-before date has expired. 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. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Component manipulation by patients. 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). All components listed must be implanted unless noted as "optional." 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. Surgical advice for removal. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. To prevent unintended stimulation, do not modify the operating system in any way. 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 unable to properly operate the system. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Caution patients to not make unauthorized changes to physician-established stimulation parameters. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. This includes oxygen-enriched environments such as hyperbaric chambers. Activities requiring coordination. 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 equipment is not serviceable by the customer. Keep them dry to avoid damage. Only apply software updates that are published directly by Abbott Medical. Implantation of multiple leads. Wireless use restrictions. Scuba diving or hyperbaric chambers. Use extreme care when handling system components. Always perform removal with the patient conscious and able to give feedback. All components listed must be implanted unless noted as "optional." The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Before reinserting the sheath, verify there is no damage to the sheath. Failure to do so may result in damage to the sheath. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Return all explanted IPGs to Abbott Medical for safe disposal. Securing the lead with the lead stabilizer will mitigate this risk. 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. Component manipulation by patient. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Failure to do so can damage or cut the lead or sheath. After defibrillation, confirm the neurostimulation system is still working. 2013;16(5):471-482. Lead insertion through sheath. Therapeutic magnets. Follow proper infection control procedures. Avoid programming either device in a unipolar mode (using the devices can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. Electrosurgery. If needed, return the equipment to Abbott Medical for service. 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. 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. For this reason, programming at frequencies less than 30 Hz is not recommended. Poor surgical risks. 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. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. 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. Store components and their packaging where they will not come in contact with liquids of any kind. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. six to eight weeks after implantation of a neurostimulation system. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Advance the needle and guidewire slowly. In rare cases, this can create a medical emergency. Restricted areas. Use caution when sedating the patient. Poor surgical risks. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. The website that you have requested also may not be optimized for your screen size. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Patient activities and environmental precautions. The following warnings apply to this neurostimulation system. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system. Sheath retraction. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Excessive lead migration may require reoperation to replace the leads. 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. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems(available online atmedical.abbott/manuals). Implanting physicians should be experienced in stereotactic and functional neurosurgery. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Consumer goods and electronic devices. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 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. Return them to Abbott Medical for proper disposal. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. Use appropriate sterile technique when implanting leads and the IPG. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. The force of the instruments may damage the lead or stylet. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. 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. Diathermy is further prohibited because it may also damage the neurostimulation system components. Magnetic resonance imaging (MRI). 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. Patients should not use this neurostimulation system if they are pregnant or nursing. 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. 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. Device modification. This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. The safety and efficacy of the implantation of greater than four leads have not been evaluated. 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. 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). Care and handling of components. Implant heating. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Remove leads slowly. Infection. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Abandoned leads and replacement leads. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Explosive and flammable gasses. 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. Anchoring leads. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Have the patient check the device for proper functioning, even if the device was turned off. Multiple leads. System testing. Conscious sedation during removal. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Electromagnetic interference (EMI). Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. An expiration date (or use-before date) is printed on the packaging. Component handling. Overcommunicating with the IPG. away from the generator and avoid placing any smart device in a pocket near the generator. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. External defibrillators. Pediatric use. For more information, see the clinician programmer manual. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Exposure to body fluids or saline. Unwanted changes in stimulation may include a jolting or shocking feeling. Output power below 80 W is recommended for all activations. Injury or damage can occur during diathermy treatment whether the neurostimulation system 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. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. 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. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Patients should be advised to not use therapeutic magnets. The implanted components of this neurostimulation system are intended for a single use only. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Advise patients about adverse effects. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Sheath insertion precaution. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Infections related to system implantation might require that the device be explanted. 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). Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted 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. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. 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.