Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. 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. 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. 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. Radiofrequency or microwave ablation. Interference with wireless equipment. Implantation of multiple leads. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Poor surgical risks. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Device modification. Equipment is not serviceable by the customer. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Return all explanted generators to Abbott Medical for safe disposal. Read this section to gather important prescription and safety information. The tip of the sheath may whip around and could cause harm to the patient. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. After defibrillation, confirm the neurostimulation system is still working. Make the Bold Choice Securing the lead with the lead stabilizer will mitigate this risk. Lead insertion through sheath. The IPG should be explanted before cremation because the IPG could explode. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. High stimulation outputs. Return the explanted IPG to Abbott Medical. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. Abbott's Proclaim XR Spinal Cord Stimulation System Now - Insider Implantation of multiple leads. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. 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. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Operation of machines, equipment, and vehicles. 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. External defibrillators. Therapeutic magnets. Charge density can be reduced by lowering the stimulation amplitude or pulse width. 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. Object Info: - MRI Safety Security, antitheft, and radiofrequency identification (RFID) devices. Surgeon training. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Neurosurgery Pain Management Orthopaedic Surgery If two systems are implanted, ensure that at least 20 cm (8 in.) INDICATIONS FOR USE Return any suspect components to Abbott Medical for evaluation. External defibrillators. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. The Proclaim XR SCS system can provide relief to . High stimulation outputs. Radiofrequency or microwave ablation. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. 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 Instructions for Use Website - SJM Follow proper infection control procedures. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. separates the implanted generators to minimize unintended interaction with other system components. Package or component damage. Activities requiring excessive twisting or stretching. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Set the electrosurgery device to the lowest possible energy setting. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Use extreme care when handling system components. Lead movement. Conscious sedation. Single-use, sterile device. IPG disposal. 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. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. 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. Wireless use restrictions. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Mobile phones. FDA Approves Abbott's Spinal Cord Stimulation for People Living with Overcommunicating with the IPG. ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. Only apply software updates that are published directly by Abbott Medical. Expiration date. Skin erosion. Do not use the system if the use-before date has expired. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. 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. Lasting Relief through our smallest system yet. Device profile of the Proclaim XR neurostimulation system for the 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. Therapeutic radiation. Application modification. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Avoid excessive stimulation. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. 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. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Care and handling of components. 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. For this reason, programming at frequencies less than 30 Hz is not recommended. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Do not crush, puncture, or burn the IPG because explosion or fire may result. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Unwanted changes in stimulation may include a jolting or shocking feeling. An expiration date (or use-before date) is printed on the packaging. Generators contain batteries as well as other potentially hazardous materials. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Stimulation effectiveness. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Operation of machinery and equipment. Do not resterilize or reimplant an explanted system for any reason. Programmer use. 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. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Magnetic resonance imaging (MRI). Patient's visual ability to read the patient controller screen. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing.
