Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Handle the device with care. Stimulation effectiveness has been established for one year. 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. Up to two leads, lead protection boots, and burr hole covers may be implanted. 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,. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Use appropriate sterile technique when implanting leads and the IPG. Providing strain relief. Follow proper infection control procedures. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. PDF View Shellock R & D Services, Inc. email: . Electromagnetic interference (EMI). This includes oxygen-enriched environments such as hyperbaric chambers. 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. 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. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Consider seeking surgical advice if you cannot easily remove a lead. Monitor the patients blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Package or component damage. Coagulopathies. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). It is extremely important to select patients appropriately for neurostimulation. Electromagnetic interference (EMI). Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. 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. Component manipulation by patient. To prevent injury or damage to the system, do not modify the equipment. The Proclaim XR SCS system can provide relief to . Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) IPG disposal. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. 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). Component disposal. Poor surgical risks. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Place the neurostimulator in Surgery mode before using an electrosurgery device. Risk of depression, suicidal ideations, and suicide. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. The website that you have requested also may not be optimized for your screen size. 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. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Sheath insertion warning. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). Infections related to system implantation might require that the device be explanted. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). The clinician programmer and patient controller contain a battery and other potentially hazardous materials. 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. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. 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. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Component manipulation. 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. Failure to do so may cause harm to the patient such as damage to the dura. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. Component manipulation by patients. Application modification. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. Securing the lead with the lead stabilizer will mitigate this risk. 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). Keep dry to avoid damage. The force of the instruments may damage the lead or stylet. Sheath rotation. 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. Bending the sheath. When multiple leads are implanted, route the lead extensions so the area between them is minimized. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Do not crush, puncture, or burn the IPG because explosion or fire may result. 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. 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. 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. 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. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. 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). Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. For more information, see the clinician programmer manual. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Confirm the neurostimulation system is functioning correctly after the procedure. Set the electrosurgery device to the lowest possible energy setting. Make the Bold Choice Diathermy is further prohibited because it may also damage the neurostimulation system components. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Electrical medical treatment. Return of symptoms and rebound effect. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Confirm the neurostimulation system is functioning. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Conscious sedation. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. 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. Stimulation Modes. Patients should be advised to not use therapeutic magnets. Conditional 5. Securing the anchor. Operation of machines, equipment, and vehicles. 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. Operation of machines, equipment, and vehicles. Therapeutic radiation. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. 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. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Computed tomography (CT). Lead damage from tools. Lead movement. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . 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. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Long-term safety and effectiveness. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Lead movement. Infections related to system implantation might require that the device be explanted. Exposure to body fluids or saline. 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. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Devices with one-hour recharge per day. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. 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. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Radiofrequency or microwave ablation. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Using surgical instruments. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support.