Return any suspect components to Abbott Medical for evaluation. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Scuba diving or hyperbaric chambers. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Operation of machines, equipment, and vehicles. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. 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. The clinician programmer and patient controller are not waterproof. Pediatric use. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). Schu S, Gulve A, ElDabe S, et al. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. If needed, return the equipment to Abbott Medical for service. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. Cremation. Anchoring leads. 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. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. 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. Component handling. 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. Infections related to system implantation might require that the device be explanted. Confirm the neurostimulation system is functioning correctly after the procedure. Skin erosion. 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. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. FDA's expanded . 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. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Number of leads implanted. 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. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Lasting Relief through our smallest system yet. Component manipulation by patients. Handle the programmers and controllers with care. Postural changes. 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. Application modification. This includes oxygen-enriched environments such as hyperbaric chambers. Object Info: - MRI Safety Needle insertion. Bending the sheath. Case damage. If the programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. 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. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Securing the lead with the lead stabilizer will mitigate this risk. 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. Advise patients about adverse effects. Inserting the anchor. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Approved models and implant locations for an MR Conditional lead-only system. Coagulopathies. 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. 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. Insertion of a sheath without the lead may result in dural puncture. Diathermy is further prohibited because it may also damage the neurostimulation system components. To prevent injury or damage to the system, do not modify the equipment. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Patient activities and environmental precautions. Follow proper infection control procedures. 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 Needle positioning. Keep programmers and controllers dry. If the stylet is removed from the lead, it may be difficult to reinsert it. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. 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 in an environment where explosive or flammable gas fumes or vapors are present. External defibrillators. 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. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. 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. 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 be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Return any suspect components to Abbott Medical for evaluation. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. ** 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. 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. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . 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. 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. 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. Patient selection. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. INDICATIONS FOR USE See Full System Components below if the patient has an IPG and extensions implanted. 737202011056 v5.0 | Item approved for U.S. use only. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Case damage. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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. 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). Electrical medical treatment. Devices with one-hour recharge per day. 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. Infections may require that the device be explanted. If lithotripsy must be used, do not focus the energy near the IPG. Physicians should also discuss any risks of MRI with patients. Exposure to body fluids or saline. Skydiving, skiing, or hiking in the mountains. Infections related to system implantation might require that the device be explanted. Do not crush, puncture, or burn the IPG because explosion or fire may result. Diathermy is further prohibited because it may also damage the neurostimulation system components. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. 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. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground.