abbott proclaim spinal cord stimulator mri safety abbott proclaim spinal cord stimulator mri safety

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 Application modification. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. High stimulation outputs and charge density limits. The equipment is not serviceable by the customer. 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. Exposure to body fluids or saline. 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. Implantation of two systems. 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. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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. If multiple leads are implanted, leads and extensions should be routed in close proximity. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. 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. In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your generator immediately.). Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Package or component damage. Proclaim XR SCS System Meaningful relief from chronic pain. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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 system if the use-before date has expired. ), 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.). Component disposal. 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. 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. Clinician training. Devices with one-hour recharge per day. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. six to eight weeks after implantation of a neurostimulation system. Radiofrequency or microwave ablation. Loss of coordination is a potential side effect of DBS therapy. 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. Implant heating. Providing strain relief. Set the electrosurgery device to the lowest possible energy setting. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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,. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Implantation of two systems. Output power below 80 W is recommended for all activations. 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. 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. Remove leads slowly. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Return all explanted components to Abbott Medical for safe disposal. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) External defibrillation can cause induced currents in the lead-extension portion of the 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 should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Stimulation in unwanted places (such as radicular stimulation of the chest wall), Lead migration, causing changes in stimulation or reduced pain relief, Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant, Persistent pain at the electrode or generator site, Seroma (mass or swelling) at the generator site, Allergic or rejection response to implant materials, Implant migration or skin erosion around the implant. 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. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. If unpleasant sensations occur, turn off stimulation immediately. If unpleasant sensations occur, the device should be turned off immediately. Therapeutic magnets. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Other active implantable devices. Radiofrequency or microwave ablation. Patient selection. Single-use, sterile device. Use extreme care when handling system components. 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. Battery precaution. Patients should cautiously approach such devices and should request help to bypass them. For this reason, programming at frequencies less than 30 Hz is not recommended. 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 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. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. 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. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. 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 Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Care and handling of components. 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 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. 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). IPGs contain batteries as well as other potentially hazardous materials. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Case damage. Sheath insertion warning. Consumer goods and electronic devices. The following precautions apply to this neurostimulation system. 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. Advancing components. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. 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. Operation of machines, equipment, and vehicles. The placement of the leads involves some risk, as with any surgical procedure. If lithotripsy must be used, do not focus the energy near the IPG. 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. Always perform removal with the patient conscious and able to give feedback. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Stimulation Modes. Patient activities and environmental precautions. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Implanted cardiac systems. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Diathermy is further prohibited because it may also damage the neurostimulation system components. Device modification. 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. 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. Implantation of two systems. Lead handling. Emergency procedures. 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. If the stylet is removed from the lead, it may be difficult to reinsert it. 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. Confirm that no adverse conditions to MR scanning are present. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Failure to do so may result in difficulty delivering the lead. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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). External defibrillators. Risk of depression, suicidal ideations, and suicide. Do not use the application if the operating system is compromised (i.e., jailbroken). Product materials. Therapeutic radiation. Operation of machinery and equipment. Keep programmers and controllers dry. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Anchoring leads. 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. Clinician training. FDA's expanded . If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Read this section to gather important prescription and safety information. The system is intended to be used with leads and associated extensions that are compatible with the system. Handle the programmers and controllers with care. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Do not suture directly onto the lead to avoid damaging the lead. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . IPG placement. 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. 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. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Remove the stylet from the lead only when satisfied with lead placement.