Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Bending the sheath. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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,. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Therapeutic magnets. 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. Recharge-by date. Additional Disadvantages. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Explosive and flammable gasses. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Implanted cardiac systems. 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. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Use care when reinserting a stylet. 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). Application modification. After defibrillation, confirm the neurostimulation system is still working. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. 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. Care and handling of components. Security, antitheft, and radiofrequency identification (RFID) devices. Mobile phones. 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. Exit Surgery mode during intraoperative testing and after the procedure is completed. Infection. Do not crush, puncture, or burn the IPG because explosion or fire may result. Implantation of multiple leads. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Use extreme care when handling system components. 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). For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Neurostimulation should not be used on patients who are poor surgical candidates. 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. See Full System Components below if the patient has an IPG and extensions implanted. Use extreme care when handling system components prior to implantation. 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. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Remove the stylet from the lead only when satisfied with lead placement. Device modification. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. January 4, 2022 By Sean Whooley. Operation of machines, equipment, and vehicles. Detailed information on storage environment is provided in the appendix of this manual. Component manipulation by patients. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. FDA's expanded . The clinician programmer and patient controller are not waterproof. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. The device should be turned off and the doctor contacted if this occurs. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. Patient selection. If lithotripsy must be used, do not focus the energy near the IPG. External defibrillators. Equipment is not serviceable by the customer. 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. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. Storage environment. Multiple leads. 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. Patients should cautiously approach such devices and should request help to bypass them. Security, antitheft, and radiofrequency identification (RFID) devices. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Have the patient check the device for proper functioning, even if the device was turned off. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. If the patient requires a CT scan, all stimulation should be turned off before the procedure. 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. 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. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Component disposal. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. If they must go through a gate or doorway containing this type of device, patients should turn off their generator and proceed with caution, being sure to move through the device quickly. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. 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). Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Diathermy is further prohibited because it may also damage the neurostimulation system components. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. Damage to the system may not be immediately detectable. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Restricted areas. Sheath insertion precaution. Unauthorized changes to stimulation parameters. After defibrillation, confirm the neurostimulation system is still working. Use appropriate sterile technique when implanting leads and the IPG. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Return all explanted components to Abbott Medical for safe disposal. Implantation at vertebral levels above T10. The website that you have requested also may not be optimized for your screen size. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Postural changes. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Radiofrequency or microwave ablation. 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. 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). This includes oxygen-enriched environments such as hyperbaric chambers. Component manipulation by patient. If unpleasant sensations occur, the IPG should be turned off immediately. If lithotripsy must be used, do not focus the energy near the IPG. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. ), 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 or breakage, Stimulation in unwanted places (such as stimulation of the chest wall), Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space Cerebrospinal fluid (CSF) leakage, Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, Pain or bleeding where the needle was inserted, Seroma (mass or swelling) at the implant site, Allergic or rejection response to device or implant materials, Hardware malfunction that requires replacing the neurostimulator, Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain, Formation of reactive tissue in the epidural space around the lead, which can cause delayed spinal cord compression and paralysis and requires surgical intervention (Time to onset can range 23 from weeks to many years after implant.). 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. The equipment is not serviceable by the customer. Application modification. Conditional 5. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Surgeon training. Needle positioning. Infections may require that the device be explanted. Patients should cautiously approach such devices and should request help to bypass them. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. 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. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. 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. Securing the lead with the lead stabilizer will mitigate this risk. Programmer use. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. High stimulation outputs. Stimulation effectiveness. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Security, antitheft, and radiofrequency identification (RFID) devices. Nerve damage may result from traumatic or surgical nerve injury. All components listed must be implanted unless noted as "optional." For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Set the electrosurgery device to the lowest possible energy setting. Electromagnetic interference (EMI). 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. 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. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Application modification. Skydiving, skiing, or hiking in the mountains. 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. Skin erosion. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 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. 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. Preventing infection. 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. High stimulation outputs. Up to two leads, lead protection boots, and burr hole covers may be implanted. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. The Proclaim XR SCS system can provide relief to . The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. 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. This means you can get 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 operation of these devices could cause them to ignite, causing severe burns, injury, or death. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Failure to provide strain relief may result in lead migration requiring a revision procedure. Do not crush, puncture, or burn the IPG because explosion or fire may result. The safety and effectiveness of neurostimulation for pediatric use have not been established. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. (2) The method of its application or use. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. If the stylet is removed from the lead, it may be difficult to reinsert it. Removing components. It is extremely important to select patients appropriately for neurostimulation. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Computed tomography (CT). Clinician training. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. To prevent injury or damage to the system, do not modify the equipment. Activities requiring excessive twisting or stretching. Schu S, Gulve A, ElDabe S, et al. Explosive and flammable gasses. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. 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. Security, antitheft, and radiofrequency identification (RFID) devices. Battery care. Damage to the system may not be immediately detectable. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Case damage. 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. Advancing components. Return them to Abbott Medical for proper disposal. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. Stylet handling. Long-term safety and effectiveness. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. To prevent injury or damage to the system, do not modify the equipment. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Infections related to system implantation might require that the device be explanted. Only apply software updates that are published directly by Abbott Medical. Physicians should also discuss any risks of MRI with patients. Operation of machines, equipment, and vehicles. Return all explanted components to Abbott Medical for safe disposal. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. 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. Use extreme care to not damage the lead with the sharp point of the tunneling tool. 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. To prevent injury or damage to the system, do not modify the equipment. Return any suspect components to Abbott Medical for evaluation. 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. The following warnings apply to this neurostimulation system. Neurosurgery Pain Management Orthopaedic Surgery 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.**. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. 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. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. 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.