To prevent injury or damage to the system, do not modify the equipment. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. 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. Electromagnetic interference (EMI). If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Product materials. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 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. System testing. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. Remove leads slowly. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Disadvantages and Risks of Spinal Cord Stimulation Lead damage from tools. 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. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Keep the device dry. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Return any suspect components to Abbott Medical for evaluation. 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. Bathing. Operation of machines, equipment, and vehicles. If unpleasant sensations occur, the IPG should be turned off immediately. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. IMAGINE A FUTURE - cloud.neuroemail.abbott.com Pain is not resolved. Lead movement. Stimulation effectiveness. Use care when reinserting a stylet. Infection. Patients should exercise reasonable caution when bathing. 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. Follow proper infection control 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Package or component damage. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). The Proclaim XR SCS system can provide relief to . However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Ensure the patients neurostimulation system is in MRI mode. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. This equipment is not serviceable by the customer. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. Implantation of two systems. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Pregnancy and nursing. 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. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. External defibrillators. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. Battery care. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. 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. Devices with one-hour recharge per day. Mobile phones. Use extreme care when handling system components prior to implantation. Advise patients about adverse effects. Operating the device near gas fumes or vapors could cause them to catch fire. Surgical advice for removal. 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. Exit Surgery mode during intraoperative testing and after the procedure is completed. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Poor surgical risks. Electromagnetic interference (EMI). The implanted components of this neurostimulation system are intended for a single use only. Component disposal. Do not crush, puncture, or burn these devices because explosion or fire may result. Implantation at vertebral levels above T10. Patient's visual ability to read the patient controller screen. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. 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. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Reducing the Pains of Chronic Pain Treatment | Abbott Newsroom If unpleasant sensations occur, turn off stimulation immediately. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. 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, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. Proclaim DRG System | Abbott 737202011056 v5.0 | Item approved for U.S. use only. IPGs contain batteries as well as other potentially hazardous materials. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Component disposal. 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). 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,. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. 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. Case damage. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, 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, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. 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. Multiple leads. ), 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.). Safety and effectiveness of neurostimulation for pediatric use have not been established. If multiple leads are implanted, leads and extensions should be routed in close proximity. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Implantation of multiple leads. radiofrequency identification (RFID) devices. Have the patient check the device for proper functioning, even if the device was turned off. 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. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. While charging the generator, patients may perceive an increase in temperature at the generator site. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. IPG placement. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Poor surgical risks. Patient training. 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.
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