72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Patients should exercise reasonable caution when bathing. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Return all explanted components to Abbott Medical for safe disposal. Remove the stylet from the lead only when satisfied with lead placement. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. 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). 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. Multiple leads. MRI Support | Abbott Neuromodulation FDA Approves Abbott's Spinal Cord Stimulation for People Living with If unpleasant sensations occur, the IPG should be turned off immediately. Security, antitheft, and radiofrequency identification (RFID) devices. Abbott Launches the World's Smallest Implantable, Rechargeable Spinal 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. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. 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. 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). Our Invisible Trial System TM is a discreet, app . Scuba diving or hyperbaric chambers. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. 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. Anchoring leads. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Damage to shallow implants. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Infections related to system implantation might require that the device be explanted. Proclaim Plus: The Next Burst in Chronic Pain Care | Abbott Newsroom 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. Read this section to gather important prescription and safety information. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Back pain. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Explosive and flammable gasses. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Operation of machines, equipment, and vehicles. Programmer use. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Abandoned leads and replacement leads. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Sheath insertion precaution. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient. If lithotripsy must be used, do not focus the energy near the generator. If they must go through a gate or doorway containing this type of device, patients should turn off their generator and proceed with caution, being sure to move through the device quickly. Lasting Relief through our smallest system yet. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. 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. Poor surgical risks. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Read this section to gather important prescription and safety information. 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. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Implantation of two systems. Patient training. 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. 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. 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Select patients appropriately for deep brain stimulation. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. communication equipment (such as microwave transmitters and high-power amateur transmitters). 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). In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Return any suspect components to Abbott Medical for evaluation. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Proclaim XR SCS System Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Nerve damage may result from traumatic or surgical nerve injury. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation. Damage to the system may not be immediately detectable. 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). These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Emergency procedures. 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. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Device modification. To prevent unintended stimulation, do not modify the operating system in any way. 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). 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. ); 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. To find Shipping Material Packaging Waste information, select Healthcare Professionals. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Schu S, Gulve A, ElDabe S, et al. 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. Do not suture directly onto the lead to avoid damaging the lead. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. If unpleasant sensations occur, the device should be turned off immediately. Implantation of two systems. Inaccurate ECG results may lead to inappropriate treatment of the patient. Clinician training. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. Security, antitheft, and radiofrequency identification (RFID) devices. High-output ultrasonics and lithotripsy. 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. Operation of machinery and equipment. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. 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. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted 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. Conscious sedation during removal. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. 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 Using surgical instruments. Have the patient check the device for proper functioning, even if the device was turned off. Neurostimulation should not be used on patients who are poor surgical candidates. 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. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device. MR safety: spinal cord stimulators - Questions and Answers in MRI For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Care and handling of components. Keep them dry to avoid damage. The system is intended to be used with leads and associated extensions that are compatible with the system. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Object Info: - MRI Safety 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. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Getting an MRI | Medtronic Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. The safety and effectiveness of neurostimulation for pediatric use have not been established. Surgeon training. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Use extreme care when handling system components prior to implantation. Lead inspection. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. 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). The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Use extreme care when handling system components. Wireless use restrictions. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Consider seeking surgical advice if you cannot easily remove a lead. 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. Patient selection. Other active implantable devices. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Use appropriate sterile technique when implanting leads and the IPG. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Failure to do so may cause harm to the patient such as damage to the dura. This may occur once the lead is in place and is connected to the neurostimulator and activated. Damage to the system may not be immediately detectable. 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. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. If radiation therapy is required, the area over the implanted generator should be shielded with lead. 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. Return all explanted components to Abbott Medical for safe disposal. Electromagnetic interference (EMI). Magnetic resonance imaging (MRI). Additional Disadvantages. Keep them dry to avoid damage. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Patients should cautiously approach such devices and should request help to bypass them. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Control of the patient controller. 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). Case damage. MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott 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. Do not use the system if the use-before date has expired. To prevent unintended stimulation, do not modify the operating system in any way. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. 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.