Infection. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Neurosurgery Pain Management Orthopaedic Surgery Radiofrequency or microwave ablation. Implantation at vertebral levels above T10. 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. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. 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. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Stimulation effectiveness. Consider seeking surgical advice if you cannot easily remove a lead. Device profile of the Proclaim XR neurostimulation system for the MRI Support | Abbott Keep them dry to avoid damage. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Pregnancy and nursing. 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. Do not crush, puncture, or burn these devices because explosion or fire may result. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Care and handling of components. After defibrillation, confirm the neurostimulation system is still working. Neurostimulation should not be used on patients who are poor surgical candidates. Abbott - Spinal Cord Stimulation Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Failure to do so can damage or cut the lead or sheath. 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. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Infections may require that the device be explanted. Always be aware of the needle tip position. Low frequencies. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Remove leads slowly. Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. Magnetic resonance imaging (MRI). Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. 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. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Proclaim XR SCS System Meaningful relief from chronic pain. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Always perform removal of implanted components with the patient conscious and able to give feedback. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. 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. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). If needed, return the equipment to Abbott Medical for service. Patients should avoid charging their generator over an incision that has not completely healed. 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 long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. 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). Patients should be advised to not use therapeutic magnets. 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. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. 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. 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. Damage to the system may not be immediately detectable. 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. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Restricted areas. 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. Abandoned leads and replacement leads. 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 components to Abbott Medical for safe disposal. Do not crush, puncture, or burn the IPG because explosion or fire may result. 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). Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Exit Surgery mode during intraoperative testing and after the procedure is completed. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). 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. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. 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. If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Patient training. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Activities requiring coordination. Electrosurgery. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Lead movement. 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. Failure to do so may result in difficulty delivering the lead. Product materials. Schu S, Gulve A, ElDabe S, et al. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Remove the stylet from the lead only when satisfied with lead placement. Infection. 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. Stimulation Modes. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. FDA Approves Abbott's Spinal Cord Stimulation for People Living with Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. If needed, return the equipment to Abbott Medical for service. Surgeon training. The following warnings apply to this neurostimulation system. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Implanted cardiac systems. Security, antitheft, and radiofrequency identification (RFID) devices. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Follow proper infection control procedures. 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. Recharge-by date. 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. 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. Removing components. 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. Spinal Cord Stimulator Systems - Boston Scientific Read this section to gather important prescription and safety information. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers 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. 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. Keep them dry to avoid damage. 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. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. The U.S. Food and Drug Administration (FDA) has approved Abbott 's request to expand the magnetic resonance imaging (MRI) compatibility with its Proclaim XR spinal cord stimulation system with . Case damage. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). The device should be turned off and the doctor contacted if this occurs. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Case damage. 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. 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. 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. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Use caution when sedating the patient. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. away from the generator and avoid placing any smart device in a pocket near the generator. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Select patients appropriately for deep brain stimulation. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. Consumer goods and electronic devices. 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. Patients should not use this neurostimulation system if they are pregnant or nursing. If lithotripsy must be used, do not focus the energy near the IPG. Exposure to body fluids or saline.