abbott proclaim spinal cord stimulator mri safety

Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Diathermy is further prohibited because it may also damage the neurostimulation system components. Detailed information on storage environment is provided in the appendix of this manual. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Infections may require that the device be explanted. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. maximize the distance between the implanted systems; Use in patients with diabetes. Electrical medical treatment. Monitor the patients blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. 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. To prevent unintended stimulation, do not modify the operating system in any way. Sheath insertion warning. Overcommunicating with the IPG. While charging the generator, patients may perceive an increase in temperature at the generator site. 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). Keep them dry to avoid damage. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Patients should avoid charging their generator over an incision that has not completely healed. Return any suspect components to Abbott Medical for evaluation. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Implantation at vertebral levels above T10. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Electrosurgery. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. MRI Support | Abbott Skin erosion. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. A recharge-by date is printed on the packaging. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers 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. Clinician training. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Battery precaution. Unauthorized changes to stimulation parameters. Application modification. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Bold New Spinal Cord Stimulation - Proclaim XR SCS System Programmer and controller devices are not waterproof. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). If patients feel that the TENS device may be interfering with the neurostimulator, patients should discontinue using the TENS device until they talk with their physician. Security, antitheft, and radiofrequency identification (RFID) devices. 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. High stimulation outputs and charge density limits. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. IPGs contain batteries as well as other potentially hazardous materials. Package or component damage. To prevent unintended stimulation, do not modify the operating system in any way. Do not resterilize or reimplant an explanted system for any reason. 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. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. six to eight weeks after implantation of a neurostimulation system. Bending the sheath. Confirm that no adverse conditions to MR scanning are present. 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. If two systems are implanted, ensure that at least 20 cm (8 in.) Read this section to gather important prescription and safety information. 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. Operation of machinery and equipment. 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 safety and effectiveness of neurostimulation for pediatric use have not been established. Free from the hassles of recharging. Neurosurgery Pain Management Orthopaedic Surgery Do not use the system if the use-before date has expired. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. To prevent injury or damage to the system, do not modify the equipment. 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. radiofrequency identification (RFID) devices. Before reinserting the sheath, verify there is no damage to the sheath. Always perform removal of implanted components with the patient conscious and able to give feedback. Pain is not resolved. Patient training. Device modification. Return the explanted IPG to Abbott Medical. Sheath rotation. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Using the tunneling tool. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. If the stylet is removed from the lead, it may be difficult to reinsert it. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Activities requiring coordination. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. 737202011056 v5.0 | Item approved for U.S. use only. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Use extreme care when handling system components. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. If two systems are implanted, ensure that at least 20 cm (8 in.) 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. External defibrillators. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS Handle the programmers and controllers with care. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. 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, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Battery care. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. commercial electrical equipment (such as arc welders and induction furnaces). Security, antitheft, and radiofrequency identification (RFID) devices. Security, antitheft, and radiofrequency identification (RFID) devices. The following precautions apply to this neurostimulation system. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Diathermy therapy. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Getting an MRI | Medtronic 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. Storage environment. Advise patients about adverse effects. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. 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. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. Approved models and implant locations for an MR Conditional lead-only system. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. 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. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Only apply software updates that are published directly by Abbott Medical. (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. Generators contain batteries as well as other potentially hazardous materials. 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. 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. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Avoid excessive stimulation. Case damage. 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. 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. 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. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Postural changes. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Physicians should also discuss any risks of MRI with patients. Patient selection. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Explosive and flammable gasses. High stimulation outputs. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. The effect of mobile phones on deep brain stimulation is unknown. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Explosive and flammable gasses. 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. Implant heating. Component disposal. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Patients who are unable to properly operate the system. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. 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. Ultrasonic scanning equipment. 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. Set the electrosurgery device to the lowest possible energy setting. The force of the instruments may damage the lead or stylet. 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). Keep programmers and controllers dry. Safety Info ID# Safety Topic / Subject Article Text 294: Spinal Cord Stimulation Systems: St. Jude Medical: Genesis, GenesisXP, GenesisRC, Eon, Eon C, Eon Mini, and Renew The Genesis, GenesisXP, GenesisRC, Eon, EonC, Eon Mini, and Renew neuromodulation devices (St. Jude Medical) used for spinal cord stimul. 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. 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). Use extreme care to not damage the lead with the sharp point of the tunneling tool. 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. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. FDA Approves Abbott's Spinal Cord Stimulation for People Living with 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. 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. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. High-output ultrasonics and lithotripsy. Excessive lead migration may require reoperation to replace the leads. Mobile phones. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. 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. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Lead damage from tools. MRI Support | Abbott Neuromodulation *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. Conscious sedation during removal. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. 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. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Lead movement. Scuba diving and hyperbaric chambers. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Scuba diving or hyperbaric chambers. Up to two leads, lead protection boots, and burr hole covers may be implanted. Poor surgical risks. The IPG should be explanted before cremation because the IPG could explode. Remove the stylet from the lead only when satisfied with lead placement. However, some patients may experience a decrease or increase in the perceived level of stimulation. 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. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Exit Surgery mode during intraoperative testing and after the procedure is completed. Electromagnetic interference (EMI). Abandoned leads and replacement leads. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). 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. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. 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. Securing the IPG. 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). Use appropriate sterile technique when implanting leads and the IPG. If multiple leads are implanted, leads and extensions should be routed in close proximity. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. Care and handling of components. Proclaim XR SCS System Meaningful relief from chronic pain. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Bathing. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. 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,. Sheath retraction. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. 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. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). 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 use surgical instruments to handle the lead. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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.

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