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. Sheath insertion warning. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. 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. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. 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. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Battery care. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Monitor the patients blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. Approved models and implant locations for an MR Conditional lead-only system. (2) The method of its application or use. Back pain. Bending the sheath. Physicians should also discuss any risks of MRI with patients. Needle insertion. 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 Read this section to gather important prescription and safety information. IPGs contain batteries as well as other potentially hazardous materials. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. If multiple leads are implanted, leads and extensions should be routed in close proximity. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. Safety and effectiveness of neurostimulation for pediatric use have not been established. Patients should not use this neurostimulation system if they are pregnant or nursing. 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. ), 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.). 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. Lead movement. Patient training. 2013;16(5):471-482. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. Implantation at vertebral levels above T10. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Implant heating. Interference with wireless equipment. Application modification. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. If lithotripsy must be used, do not focus the energy near the IPG. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. 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. Preventing infection. INDICATIONS FOR USE In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Do not crush, puncture, or burn the IPG because explosion or fire may result. Neuromodulation | For Consumers | Abbott U.S. 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 over-manipulate the sheath and lead system as this may result in trauma within the epidural space. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. 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). 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Patient training. Neurostimulation should not be used on patients who are poor surgical candidates. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. commercial electrical equipment (such as arc welders and induction furnaces). Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Clinician programmers, patient controllers, and chargers are not waterproof. Keep them dry to avoid damage. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Use extreme care to not damage the lead with the sharp point of the tunneling tool. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Patients should cautiously approach such devices and should request help to bypass them. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. To prevent injury or damage to the system, do not modify the equipment. Poor surgical risks. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Long-term safety and effectiveness. Pediatric use. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Keep dry to avoid damage. Electromagnetic interference (EMI). Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Keep the device dry. Using the tunneling tool. PATIENTS Stylet handling. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. 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. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. Programmer use. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Coagulopathies. Implanted cardiac systems. 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. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Why Proclaim XR SCS System - Abbott Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. The IPG should be explanted before cremation because the IPG could explode. Device modification. Return of symptoms and rebound effect. Use caution when sedating the patient. 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. Radiofrequency or microwave ablation. 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. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. 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. 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.). Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide.
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