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. 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. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. When multiple leads are implanted, route the lead extensions so the area between them is minimized. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. If radiation therapy is required, the area over the implanted generator should be shielded with lead. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). 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. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Application modification. Ultrasonic scanning equipment. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. 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. Poor surgical risks. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. Infection. Do not crush, puncture, or burn these devices because explosion or fire may result. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. The Proclaim XR SCS system can provide relief to . The system is intended to be used with leads and associated extensions that are compatible with the system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Generators contain batteries as well as other potentially hazardous materials. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. 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. 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. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Security, antitheft, and radiofrequency identification (RFID) devices. IPGs contain batteries as well as other potentially hazardous materials. Pediatric use. Infections may require that the device be explanted. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Confirm that no adverse conditions to MR scanning are present. Patients should exercise reasonable caution when bathing. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. 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. 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. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. Wireless use restrictions. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. This includes oxygen-enriched environments such as hyperbaric chambers. Recharge-by date. The force of the instruments may damage the lead or stylet. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. 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. Store components and their packaging where they will not come in contact with liquids of any kind. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Physicians should also discuss any risks of MRI with patients. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Patient training. 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. Infection.
Disadvantages and Risks of Spinal Cord Stimulation Needle positioning. This may occur once the lead is in place and is connected to the neurostimulator and activated. Return all explanted components to Abbott Medical for safe disposal. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Scuba diving or hyperbaric chambers. Always be aware of the needle tip position. Failure to do so may result in difficulty delivering the lead. Stabilizing the lead during insertion. Case damage. Stimulation Modes. Number of leads implanted. 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. 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). High-output ultrasonics and lithotripsy. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. 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. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Therapeutic radiation. Return all explanted components to Abbott Medical for safe disposal. Battery care. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. This neurostimulation 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. While charging the generator, patients may perceive an increase in temperature at the generator site. Some of this systems electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Clinician training. Magnetic resonance imaging (MRI). Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S. - New U.S. FDA-approved labeling lifts restrictions on 60-centimeter Octrode leads, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves 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. Lead inspection. Low frequencies. maximize the distance between the implanted systems; Use in patients with diabetes. 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. If needed, return the equipment to Abbott Medical for service. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Return the explanted IPG to Abbott Medical. External defibrillators. 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. Mobile phones. 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.