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. Schu S, Gulve A, ElDabe S, et al. The placement of the leads involves some risk, as with any surgical procedure. Operation of machines, equipment, and vehicles. Unauthorized changes to stimulation parameters. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Conscious sedation during removal. Nerve damage may result from traumatic or surgical nerve injury. Devices with one-hour recharge per day. Insertion of a sheath without the lead may result in dural puncture. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. 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). Do not suture directly onto the lead to avoid damaging the lead. 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. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Device modification. 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. 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. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Free from the hassles of recharging. Use caution when sedating the patient. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Programmer use. MR safety: spinal cord stimulators - Questions and Answers in MRI FDA's expanded . All components listed must be implanted unless noted as "optional." The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Handle the device with care. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. If unpleasant sensations occur, turn off stimulation immediately. Scuba diving or hyperbaric chambers. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. 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. Placement of lead connection in neck. Storage environment. External defibrillators. 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. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. 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. INDICATIONS FOR USE 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. Set the electrosurgery device to the lowest possible energy setting. 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. Approved models and implant locations for an MR Conditional lead-only system. Our Invisible Trial System TM is a discreet, app . 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. 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 . 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. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Infection. Proclaim Plus: The Next Burst in Chronic Pain Care | Abbott Newsroom Return all explanted generators to Abbott Medical for safe disposal. 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. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. Activities requiring coordination. 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. Implant heating. In rare cases, this can create a medical emergency. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. If needed, return the equipment to Abbott Medical for service. Application modification. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Have the patient check the device for proper functioning, even if the device was turned off. Do not use the system if the use-before date has expired. 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. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. To prevent unintended stimulation, do not modify the operating system in any way. 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. 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. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Do not crush, puncture, or burn the generator because explosion or fire may result. 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. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Use care when reinserting a stylet. Lasting Relief through our smallest system yet. This equipment is not serviceable by the customer. Damage to the system may not be immediately detectable. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Avoid programming either device in a unipolar mode (using the devices can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Wireless use restrictions. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Exposure to body fluids or saline. 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. If unpleasant sensations occur, the IPG should be turned off immediately. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Therapeutic magnets. Restricted areas. Patients should cautiously approach such devices and should request help to bypass them. Explosive and flammable gasses. Implantation at vertebral levels above T10. Spinal Cord Stimulator Systems - Boston Scientific Securing the IPG. 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. Needle insertion. High stimulation outputs and charge density limits. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. Before reinserting the sheath, verify there is no damage to the sheath. Case damage. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Return of symptoms and rebound effect. Physicians should also discuss any risks of MRI with patients. 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. Device modification. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. 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 Lead movement. Advance the needle and guidewire slowly. 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. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Avoid programming either device in a unipolar mode (using the devices can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. The safety and efficacy of the implantation of greater than four leads have not been evaluated. 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). During the implant procedure, if an electrosurgery device must be used, take the following actions:. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Security, antitheft, and radiofrequency identification (RFID) devices. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. If the stylet is removed from the lead, it may be difficult to reinsert it. Do not crush, puncture, or burn the IPG because explosion or fire may result. FDA Approves Abbott's Spinal Cord Stimulation for People Living with