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. Consider seeking surgical advice if you cannot easily remove a lead. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Damage to the system may not be immediately detectable. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. Confirm the neurostimulation system is functioning. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Approved models and implant locations for an MR Conditional lead-only system. The IPG should be explanted before cremation because the IPG could explode. Follow proper infection control procedures. This may occur once the lead is in place and is connected to the neurostimulator and activated. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Before reinserting the sheath, verify there is no damage to the sheath. Patient selection. System testing. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. 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. 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. Exit Surgery mode during intraoperative testing and after the procedure is completed. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Proclaim XR SCS System Meaningful relief from chronic pain. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Only apply software updates that are published directly by Abbott Medical. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Ensure the patients neurostimulation system is in MRI mode. Remove leads slowly (at a suggested rate of 1 cm/s while holding the lead between the thumb and forefinger) to avoid breaking the lead and leaving fragments in the patient. Placement of lead connection in neck. Operation of machinery and equipment. Explosive and flammable gasses. 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. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Sheath insertion precaution. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Patients should cautiously approach such devices and should request help to bypass them. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). 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. 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. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. If lithotripsy must be used, do not focus the energy near the IPG. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. The website that you have requested also may not be optimized for your screen size. To prevent unintended stimulation, do not modify the operating system in any way. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Electrosurgery. Implantation at vertebral levels above T10. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). 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. 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). 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. Package or component damage. Explosive and flammable gasses. Stimulation Modes. 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. Securing the IPG. Detailed information on storage environment is provided in the appendix of this manual. Household appliances. Coagulopathies. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. Return the explanted IPG to Abbott Medical. However, some patients may experience a decrease or increase in the perceived level of stimulation. Operation of machines, equipment, and vehicles. High stimulation outputs. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Magnetic resonance imaging (MRI). 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. Implantation of multiple leads. Securing the anchor. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Stylet handling. 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. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Component disposal. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Infections related to system implantation might require that the device be explanted. External defibrillators. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Neurostimulation should not be used on patients who are poor surgical candidates. For more information, see the clinician programmer manual. Return of symptoms and rebound effect. To find Shipping Material Packaging Waste information, select Healthcare Professionals. 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. Failure to provide strain relief may result in lead migration requiring a revision procedure. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. The equipment is not serviceable by the customer. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Do not suture directly onto the lead to avoid damaging the lead. A recharge-by date is printed on the packaging. Infections related to system implantation might require that the device be explanted. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS systems(available online atmedical.abbott/manuals). If multiple leads are implanted, leads and extensions should be routed in close proximity. 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 unpleasant sensations occur, the IPG should be turned off immediately. Read this section to gather important prescription and safety information. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. 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. Operating the device near gas fumes or vapors could cause them to catch fire. Patients should be advised to not use therapeutic magnets. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. If interference occurs, try holding the phone to the other ear or turning off the phone. 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. 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. 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. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. High stimulation outputs and charge density limits. 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. Do not use surgical instruments to handle the lead. The tip of the sheath may whip around and could cause harm to the patient. 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. INDICATIONS FOR USE Operation of machines, equipment, and vehicles. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Keep the device dry. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator.