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. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Return them to Abbott Medical for proper disposal. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. Placing the IPG. Household appliances. Patients should cautiously approach such devices and should request help to bypass them. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Providing strain relief. 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. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). INDICATIONS FOR USE Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Avoid excessive stimulation. Store components and their packaging where they will not come in contact with liquids of any kind. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, 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, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. 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. Package or component damage. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Scuba diving or hyperbaric chambers. Case damage. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Consumer goods and electronic devices. Proclaim DRG System | Abbott Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. An expiration date (or use-before date) is printed on the packaging. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Electrosurgery. Do not use the system if the use-before date has expired. Securing the IPG. This may occur once the lead is in place and is connected to the neurostimulator and activated. FDA's expanded . Lead insertion through sheath. Neurostimulation should not be used on patients who are poor surgical candidates. Physicians should also discuss any risks of MRI with patients. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Number of leads implanted. Proclaim XR SCS System Meaningful relief from chronic pain. Do not use surgical instruments to handle the lead. The following warnings apply to this neurostimulation system. Set the electrosurgery device to the lowest possible energy setting. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Magnetic resonance imaging (MRI). High stimulation outputs. 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. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Generators contain batteries as well as other potentially hazardous materials. 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. Device profile of the Proclaim XR neurostimulation system for the 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.**. Application modification. Abbott Launches the World's Smallest Implantable, Rechargeable Spinal 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. 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 . Care and handling of components. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Failure to provide strain relief may result in lead migration requiring a revision procedure. It is extremely important to select patients appropriately for neurostimulation. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Postural changes. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Component disposal. Lead movement. Inaccurate ECG results may lead to inappropriate treatment of the patient. For this reason, programming at frequencies less than 30 Hz is not recommended. Exit Surgery mode during intraoperative testing and after the procedure is completed. 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. Operation of machines, equipment, and vehicles. 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. The website that you have requested also may not be optimized for your screen size. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. 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. 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. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Lead damage from tools. Inserting the anchor. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. 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). Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. 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. 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. 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. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. maximize the distance between the implanted systems; Use in patients with diabetes. Spinal Cord Stimulator Systems - Boston Scientific (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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, cause heating at the lead tip that could result in tissue damage, 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. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. 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. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Long-term safety and effectiveness. 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). The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Charge density can be reduced by lowering the stimulation amplitude or pulse width. FDA approves new MRI compatibility for Abbott's Proclaim spinal cord Lead movement. Patient selection. Return any suspect components to Abbott Medical for evaluation. If unpleasant sensations occur, the IPG should be turned off immediately. separates the implanted IPGs to minimize unintended interaction with other system components. The IPG should be explanted before cremation because the IPG could explode. 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. Other active implantable devices. 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 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. Case damage. 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. 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. 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. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. All components listed must be implanted unless noted as "optional." Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Reducing the Pains of Chronic Pain Treatment | Abbott Newsroom Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. 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.