abbott proclaim spinal cord stimulator mri safety

Before reinserting the sheath, verify there is no damage to the sheath. 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. six to eight weeks after implantation of a neurostimulation system. 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. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. High-output ultrasonics and lithotripsy. Explosive and flammable gasses. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. 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. 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. 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). 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. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. 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. Electromagnetic interference (EMI). For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Pregnancy and nursing. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. To prevent unintended stimulation, do not modify the operating system in any way. 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. Do not crush, puncture, or burn the generator because explosion or fire may result. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Implant heating. 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. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Confirm the neurostimulation system is functioning correctly after the procedure. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. 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. Handle the programmers and controllers with care. The effect of mobile phones on deep brain stimulation is unknown. 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. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Diathermy is further prohibited because it may also damage the neurostimulation system components. Select patients appropriately for deep brain stimulation. 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. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Up to two leads, lead protection boots, and burr hole covers may be implanted. 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). The following warnings apply to this neurostimulation system. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Security, antitheft, and radiofrequency identification (RFID) devices. Abbott's Proclaim XR Spinal Cord Stimulation System Now - Insider Operating the device near gas fumes or vapors could cause them to catch fire. Physicians should also discuss any risks of MRI with patients. If two systems are implanted, ensure that at least 20 cm (8 in.) Placement of lead connection in neck. 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. 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. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Patients should cautiously approach such devices and should request help to bypass them. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Clinician training. Approved models and implant locations for an MR Conditional lead-only system. Magnetic resonance imaging (MRI). Patient's visual ability to read the patient controller screen. Do not suture directly onto the lead to avoid damaging the lead. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Programmer use. Operation of machinery and equipment. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. The tip of the sheath may whip around and could cause harm to the patient. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Devices with one-hour recharge per day. Security, antitheft, and radiofrequency identification (RFID) devices. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. 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. Sheath rotation. Multiple leads. Generator disposal. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Security, antitheft, and radiofrequency identification (RFID) devices. 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. Return all explanted generators to Abbott Medical for safe disposal. 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. Inaccurate ECG results may lead to inappropriate treatment of the patient. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Implantation of multiple leads. 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. 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. 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 The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. Securing the anchor. Package or component damage. Detailed information on storage environment is provided in the appendix of this manual. To prevent injury or damage to the system, do not modify the equipment. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. If unpleasant sensations occur, turn off stimulation immediately. 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. Free from the hassles of recharging. The system is intended to be used with leads and associated extensions that are compatible with the system. The system is intended to be used with leads and associated extensions that are compatible with the system. Component handling. Device modification. Stimulation effectiveness has been established for one year. 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 . The safety and effectiveness of neurostimulation for pediatric use have not been established. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. 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. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Consider seeking surgical advice if you cannot easily remove a lead. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Scuba diving or hyperbaric chambers. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations.