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 full system, *The IPG port plug associated with these models is also an MR Conditional component. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Free from the hassles of recharging. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. Return of symptoms and rebound effect. Keep them dry to avoid damage. 737202011056 v5.0 | Item approved for U.S. use only. Before reinserting the sheath, verify there is no damage to the sheath. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Wireless use restrictions. If needed, return the equipment to Abbott Medical for service. 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. Electrical medical treatment. Surgeon training. 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. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. The website that you have requested also may not be optimized for your screen size. 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). Electromagnetic interference (EMI). Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Lead inspection. Generators contain batteries as well as other potentially hazardous materials. Inaccurate ECG results may lead to inappropriate treatment of the patient. Inserting the anchor. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Application modification. This includes oxygen-enriched environments such as hyperbaric chambers. Coagulopathies. Operation of machines, equipment, and vehicles. Ensure the patients neurostimulation system is in MRI mode. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Anchoring leads. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Changes in blood glucose levels in response to any adverse effect Placement of lead connection in neck. Exposure to body fluids or saline. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. Neurostimulation systems have materials that come in contact or may come in contact with tissue. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Confirm that no adverse conditions to MR scanning are present. Confirm the neurostimulation system is functioning. Only apply software updates that are published directly by Abbott Medical. Product materials. To prevent unintended stimulation, do not modify the operating system in any way. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Package or component damage. 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. Overcommunicating with the IPG. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. 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. Patients should cautiously approach such devices and should request help to bypass them. communication equipment (such as microwave transmitters and high-power amateur transmitters). The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. 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. FDA's expanded . Radiofrequency or microwave ablation. High-output ultrasonics and lithotripsy. 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. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. All components listed must be implanted unless noted as "optional." If needed, return the equipment to Abbott Medical for service. Multiple leads. Pregnancy and nursing. Component manipulation by patient. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. 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. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. 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. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Have the patient check the device for proper functioning, even if the device was turned off. If two systems are implanted, ensure that at least 20 cm (8 in.) A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Infection. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation 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. Household appliances. ** Return all explanted components to Abbott Medical for safe disposal. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. PDF View Shellock R & D Services, Inc. email: . The device should be turned off and the doctor contacted if this occurs. 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. 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. Approved models and implant locations for an MR Conditional lead-only system. Wireless communications equipment, such as mobile and cordless phones and walkie-talkies, may interfere with the IPG if the equipment gets too close to the IPG. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. Explosive and flammable gasses. Component manipulation by patients. Patients should exercise reasonable caution when bathing. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Unwanted changes in stimulation may include a jolting or shocking feeling. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) High stimulation outputs. For this reason, programming at frequencies less than 30 Hz is not recommended. Handle the device with care. Physicians should also discuss any risks of MRI with patients. Storage environment. Do not resterilize or reimplant an explanted system for any reason. six to eight weeks after implantation of a neurostimulation system. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. If the patient requires a CT scan, all stimulation should be turned off before the procedure. The Proclaim XR SCS system can provide relief to . In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Lasting Relief through our smallest system yet. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Use extreme care when handling system components prior to implantation. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). 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. 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. High stimulation outputs. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. 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). Exit Surgery mode during intraoperative testing and after the procedure is completed. Do not crush, puncture, or burn the IPG because explosion or fire may result. Pregnancy and nursing. Safety and effectiveness of neurostimulation for pediatric use have not been established. Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Scuba diving and hyperbaric chambers. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Use care when reinserting a stylet. Conscious sedation during removal. 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). Sheath retraction. Diathermy is further prohibited because it may also damage the neurostimulation system components. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Lead movement. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. 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. Security, antitheft, and radiofrequency identification (RFID) devices. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Deep brain stimulation complications include, but are not limited to, the following: Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture, Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture, Initial jolt or tingling during stimulation; jolting or shocking sensations, Lead fracture, migration, or dislodgement, Extension malfunction, fracture, or disconnect, Deep brain stimulation system failure or battery failure within the device, Deep brain stimulation system malfunction or dislodgement, Allergic or rejection response to implanted materials, Persistent pain, tightness, or redness at the incision sites or general pain, General erosion or local skin erosion over the IPG, Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck), Impaired wound healing (e.g., incision site drainage) or abscess formation, Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component, Stimulation-related complications or other complications, Worsening of motor impairment and Parkinsons disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia, Paresis, asthenia, hemiplegia, or hemiparesis, Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance, Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia, Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium, Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope), Eye disorder including eye apraxia or blepharospasm, (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. Infection. Operating the device near gas fumes or vapors could cause them to catch fire. Removing components. A recharge-by date is printed on the packaging. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. However, some patients may experience a decrease or increase in the perceived level of stimulation. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. 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. 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. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. 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. Diathermy therapy. See Full System Components below if the patient has an IPG and extensions implanted. While charging the generator, patients may perceive an increase in temperature at the generator site. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. 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. Pediatric use. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. 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 . The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. 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. It is extremely important to select patients appropriately for neurostimulation. This damage could result in loss of therapy, requiring additional surgery for system replacement. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. 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. This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II.**. Poor surgical risks. 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. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Poor surgical risks. Read this section to gather important prescription and safety information. 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 at medical.abbott/manuals). Poor surgical risks. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. 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. Electrosurgery. Store components and their packaging where they will not come in contact with liquids of any kind. Magnetic resonance imaging (MRI). Follow proper infection control procedures. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) The system is intended to be used with leads and associated extensions that are compatible with the system. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Back pain. 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. If lithotripsy must be used, do not focus the energy near the generator. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. 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 crush, puncture, or burn the generator because explosion or fire may result. Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. If unpleasant sensations occur, the IPG should be turned off immediately. Failure to do so may result in difficulty delivering the lead. 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. Proclaim XR SCS System Meaningful relief from chronic pain. High stimulation outputs and charge density limits. Return any suspect components to Abbott Medical for evaluation. Conditional 5. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. 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. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. The following warnings apply to this neurostimulation system. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Keep programmers and controllers dry. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. 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. 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. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Lead movement. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. High-output ultrasonics and lithotripsy. To prevent unintended stimulation, do not modify the operating system in any way. Patient's visual ability to read the patient controller screen. Patient selection. When multiple leads are implanted, route the lead extensions so the area between them is minimized. 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.