Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Stylet handling. 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. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Anchoring leads. 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. 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. Changes in blood glucose levels in response to any adverse effect
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. Scuba diving or hyperbaric chambers. Set the electrosurgery device to the lowest possible energy setting. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Use extreme care when handling system components. Implantation at vertebral levels above T10. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. If two systems are implanted, ensure that at least 20 cm (8 in.) 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. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Use care when reinserting a stylet. Before reinserting the sheath, verify there is no damage to the sheath. Devices with one-hour recharge per day. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. Case damage. See Full System Components below if the patient has an IPG and extensions implanted. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. Operation of machines, equipment, and vehicles. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). six to eight weeks after implantation of a neurostimulation system. The following precautions apply to this neurostimulation system. 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. It is extremely important to select patients appropriately for neurostimulation. 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. 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. Emergency procedures. Diathermy therapy. 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. Operating the device near gas fumes or vapors could cause them to catch fire. Interference with other devices. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Generator disposal. Additional Disadvantages. Return all explanted IPGs to Abbott Medical for safe disposal. Excessive lead migration may require reoperation to replace the leads. 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. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Patient selection. Do not crush, puncture, or burn the IPG because explosion or fire may result. 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. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Application modification. Removing each item in slow movements while holding the remaining components in place will assist this process. Recharge-by date. Patients should cautiously approach such devices and should request help to bypass them. Skydiving, skiing, or hiking in the mountains. 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. Keep them dry to avoid damage. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. 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. Handle the device with care. Always perform removal with the patient conscious and able to give feedback. Package or component damage. 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. 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. This neurostimulation system is contraindicated for patients who are. Ensure the patients neurostimulation system is in MRI mode. Use appropriate sterile technique when implanting leads and the IPG. 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. January 4, 2022 By Sean Whooley. Device modification. Sheath rotation. The system is intended to be used with leads and associated extensions that are compatible with the system. communication equipment (such as microwave transmitters and high-power amateur transmitters). In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Proclaim XR SCS System Meaningful relief from chronic pain. Therapeutic radiation. Patients should cautiously approach such devices and should request help to bypass them. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Follow proper infection control procedures. Exit Surgery mode during intraoperative testing and after the procedure is completed. Keep programmers and controllers dry. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. 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 exercise reasonable caution when bathing. 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). 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. 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. Keep them dry to avoid damage. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. The placement of the leads involves some risk, as with any surgical procedure. 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. Damage to the system may not be immediately detectable. 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. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. 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. Return all explanted components to Abbott Medical for safe disposal. Stabilizing the lead during insertion. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. **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. Patient activities and environmental precautions. Bathing. The safety and effectiveness of neurostimulation for pediatric use have not been established. 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. 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. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Neurostimulation should not be used on patients who are poor surgical candidates. Return any suspect components to Abbott Medical for evaluation. 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. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Implantation of two systems. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Follow proper infection control procedures. 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. Poor surgical risks. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. 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. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. To prevent unintended stimulation, do not modify the generator software in any way. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Scuba diving and hyperbaric chambers. 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. 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). Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Household appliances. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Mobile phones. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. The Eterna Spinal Cord Stimulation (SCS) 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. Control of the patient controller. PATIENTS 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. 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. Neurosurgery Pain Management Orthopaedic Surgery 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. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. 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). Security, antitheft, and radiofrequency identification (RFID) devices. Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Neuromodulation. Charge density can be reduced by lowering the stimulation amplitude or pulse width. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve.