Follow proper infection control procedures. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Magnetic resonance imaging (MRI). Advancing components. Diathermy is further prohibited because it may also damage the neurostimulation system components. Sheath retraction. 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. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Stabilizing the lead during insertion. Failure to do so may result in difficulty delivering the lead. 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,. Remove the stylet from the lead only when satisfied with lead placement. Implanted cardiac systems. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Always perform removal with the patient conscious and able to give feedback. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. 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. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Follow proper infection control procedures. Learn more about the scan details for our MR Conditional products below. 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). Lead movement. Device modification. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. 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. Patients should cautiously approach such devices and should request help to bypass them. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. 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 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. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). ), 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 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. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. 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 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. Emergency procedures. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Wireless use restrictions. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. To prevent unintended stimulation, do not modify the operating system in any way. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. 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. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Preventing infection. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Generators contain batteries as well as other potentially hazardous materials. Up to two leads, lead protection boots, and burr hole covers may be implanted. 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. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. The Proclaim TM SCS System is also the first upgradeable and recharge-free spinal cord stimulation system capable of delivering both tonic stimulation and Abbott's proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain. Operation of machines, equipment, and vehicles. 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. Return any suspect components to Abbott Medical for evaluation. 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. Damage to shallow implants. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. To prevent injury or damage to the system, do not modify the equipment. Storage environment. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. To prevent injury or damage to the system, do not modify the equipment. Implantation at vertebral levels above T10. 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 . Component manipulation by patients. Use appropriate sterile technique when implanting leads and the IPG. Advise patients about adverse effects. Household appliances. Damage to the system may not be immediately detectable. If lithotripsy must be used, do not focus the energy near the generator. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. Follow proper infection control procedures. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Electromagnetic interference (EMI). Conscious sedation. Lead movement. 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 . Abandoned leads and replacement leads. Store components and their packaging where they will not come in contact with liquids of any kind. Lead inspection. Have the patient check the device for proper functioning, even if the device was turned off. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. 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). 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. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. 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. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Infection. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Application modification. Return all explanted generators to Abbott Medical for safe disposal. Case damage. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. In rare cases, this can create a medical emergency. Always perform removal of implanted components with the patient conscious and able to give feedback. High-output ultrasonics and lithotripsy. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Therapeutic radiation. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. For this reason, programming at frequencies less than 30 Hz is not recommended. Overcommunicating with the IPG. 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. Physicians should also discuss any risks of MRI with patients. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. Clinician training. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. Lead insertion through sheath. 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. 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. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. 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. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Scuba diving or hyperbaric chambers. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Back pain. 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. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. 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. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations.