Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. 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. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. 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. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. 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 safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. 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. High-output ultrasonics and lithotripsy. 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. Removing components. 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). Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . 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. Do not use excessive pressure when injecting through the sheath. Implant heating. Anchoring leads. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Follow proper infection control procedures. Electrosurgery. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. However, some patients may experience a decrease or increase in the perceived level of stimulation. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. 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. Our Invisible Trial System TM is a discreet, app . Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers 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. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 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. Place the neurostimulator in Surgery mode before using an electrosurgery device. Return any suspect components to Abbott Medical for evaluation. Conscious sedation during removal. Consider seeking surgical advice if you cannot easily remove a lead. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Patients should cautiously approach such devices and should request help to bypass them. Security, antitheft, and radiofrequency identification (RFID) devices. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. A summary of the safety and clinical performance (SSCP) for these devices will be published at https://ec.europa.eu/tools/eudamed by the Notified Bodies in accordance with the requirements of EU MDR 2017/745 and associated timelines. Patient training. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Implantation of multiple leads. 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. IPG disposal. Patients should avoid charging their generator over an incision that has not completely healed. Changes in blood glucose levels in response to any adverse effect **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. Unauthorized changes to stimulation parameters. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Read this section to gather important prescription and safety information. Poor surgical risks. Therapeutic radiation. 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. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. 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. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. Failure to do so may result in difficulty delivering the lead. 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. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. After defibrillation, confirm the neurostimulation system is still working. The system is intended to be used with leads and associated extensions that are compatible with the system. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. An expiration date (or use-before date) is printed on the packaging. Implantation at vertebral levels above T10. Before reinserting the sheath, verify there is no damage to the sheath. Handle the device with care. If interference occurs, try holding the phone to the other ear or turning off the phone. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Cremation. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Using surgical instruments. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. If needed, return the equipment to Abbott Medical for service. Overcommunicating with the IPG. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. The placement of the leads involves some risk, as with any surgical procedure. If the patient requires a CT scan, all stimulation should be turned off before the procedure. If needed, return the equipment to Abbott Medical for service. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Mobile phones. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. This equipment is not serviceable by the customer. Getting an MRI | Medtronic 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. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. 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. Schu S, Gulve A, ElDabe S, et al. 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. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Placing 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. High stimulation outputs. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Confirm implant locations and scan requirements for the patients system. Electromagnetic interference (EMI). 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. All components listed must be implanted unless noted as "optional." Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. 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.