For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. 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 the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. Interference with other devices. Ultrasonic scanning equipment. Consumer goods and electronic devices. ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. Storage environment. Battery precaution. Multiple leads. 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. High-output ultrasonics and lithotripsy. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Patient selection. High stimulation outputs. Infection. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. 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. Patient selection. Failure to do so may result in difficulty delivering the lead. To prevent injury or damage to the system, do not modify the equipment. commercial electrical equipment (such as arc welders and induction furnaces). Clinician training. 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. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Emergency procedures. Implantation of two systems. Needle insertion. Follow proper infection control procedures. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. The Proclaim XR SCS system can provide relief to . 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. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Pediatric use. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Detailed information on storage environment is provided in the appendix of this manual. Removing a kinked sheath. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Operation of machines, equipment, and vehicles. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Make the Bold Choice To prevent unintended stimulation, do not modify the operating system in any way. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Do not use excessive pressure when injecting through the sheath. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. High-output ultrasonics and lithotripsy. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Read this section to gather important prescription and safety information. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Do not use the application if the operating system is compromised (i.e., jailbroken). The IPG should be explanted before cremation because the IPG could explode. radiofrequency identification (RFID) devices. Wireless communications equipment, such as mobile and cordless phones and walkie-talkies, may interfere with the IPG if the equipment gets too close to the IPG. The equipment is not serviceable by the customer. Wireless use restrictions. Remove leads slowly. Advancing components. Device modification. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation. Infections may require that the device be explanted. ), 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.). Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Caution patients to not make unauthorized changes to physician-established stimulation parameters. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Patient's visual ability to read the patient controller screen. Patients should cautiously approach such devices and should request help to bypass them. Securing the lead with the lead stabilizer will mitigate this risk. 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. Security, antitheft, and radiofrequency identification (RFID) devices. Transcutaneous electrical nerve stimulation (TENS). 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. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Device modification. Securing the IPG. Lead movement. During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. If two systems are implanted, ensure that at least 20 cm (8 in.) Wireless use restrictions. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. While charging the generator, patients may perceive an increase in temperature at the generator site. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Implantation of multiple leads. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. 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. 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. Return all explanted IPGs to Abbott Medical for safe disposal. Therapeutic radiation. 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. Confirm the neurostimulation system is functioning correctly after the procedure. Equipment is not serviceable by the customer. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. 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. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Bending the sheath. 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. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Additional Disadvantages. For more information, see the clinician programmer manual. High stimulation outputs. Pregnancy and nursing. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Magnetic resonance imaging (MRI). Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. 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. 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. 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. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. 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. 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. High stimulation outputs and charge density limits. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. 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. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Recharge-by date. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Neuromodulation. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Return the explanted IPG to Abbott Medical. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Radiofrequency or microwave ablation. 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. Placement of lead connection in neck. The following precautions apply to this neurostimulation system. Programmer use. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. 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. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Clinician programmers, patient controllers, and chargers are not waterproof.