If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. 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. Implantation of two systems. IPGs contain batteries as well as other potentially hazardous materials. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. 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). 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. Excessive lead migration may require reoperation to replace the leads. 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. Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. The system is intended to be used with leads and associated extensions that are compatible with the system. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Have the patient check the device for proper functioning, even if the device was turned off. Poor surgical risks. Do not crush, puncture, or burn these devices because explosion or fire may result. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Output power below 80 W is recommended for all activations. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. Device profile of the Proclaim XR neurostimulation system for the Patients should cautiously approach such devices and should request help to bypass them. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. MRI Support | Abbott High stimulation outputs. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Consumer goods and electronic devices. Postural changes. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite. Activities requiring coordination. Advise patients about adverse effects. 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. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Do not crush, puncture, or burn the IPG because explosion or fire may result. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Neuromodulation. Case damage. This may occur once the lead is in place and is connected to the neurostimulator and activated. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers 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. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Implantation of multiple leads. (2) The method of its application or use. Confirm the neurostimulation system is functioning. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation. Patients should be advised to not use therapeutic magnets. 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), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). Patient selection. PDF View Shellock R & D Services, Inc. email: . 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. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. away from the generator and avoid placing any smart device in a pocket near the generator. Therapeutic radiation. Return them to Abbott Medical for proper disposal. Infection. Generators contain batteries as well as other potentially hazardous materials. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. If two systems are implanted, ensure that at least 20 cm (8 in.) Lead inspection. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. 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. Schu S, Gulve A, ElDabe S, et al. Wireless use restrictions. Consumer goods and electronic devices. The system is intended to be used with leads and associated extensions that are compatible with the system. Patient training. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Diathermy is further prohibited because it may also damage the neurostimulation system components. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. 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. Preventing infection. Follow proper infection control procedures. 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. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Infection. To prevent unintended stimulation, do not modify the operating system in any way. If lithotripsy must be used, do not focus the energy near the IPG. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. To prevent unintended stimulation, do not modify the generator software in any way. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. IMAGINE A FUTURE - cloud.neuroemail.abbott.com If two systems are implanted, ensure that at least 20 cm (8 in.) Pregnancy and nursing. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS Component manipulation by patients. IPGs contain batteries as well as other potentially hazardous materials. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Programmer use. Avoid excessive stimulation. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. 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). Devices with one-hour recharge per day. Return any suspect components to Abbott Medical for evaluation. 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. Surgical advice for removal. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Disadvantages and Risks of Spinal Cord Stimulation 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 following precautions apply to this neurostimulation system. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. INDICATIONS FOR USE 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. Keep dry to avoid damage. Programmer and controller devices are not waterproof.