Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. 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. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Sheath insertion precaution. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Return all explanted generators to Abbott Medical for safe disposal. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Poor surgical risks. Set the electrosurgery device to the lowest possible energy setting. Emergency procedures. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. 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. Surgical advice for removal. Package or component damage. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. The system is intended to be used with leads and associated extensions that are compatible with the system. 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. commercial electrical equipment (such as arc welders and induction furnaces). The website that you have requested also may not be optimized for your screen size. Care and handling of components. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Damage to the system may not be immediately detectable. 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. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. 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. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Failure to do so can damage or cut the lead or sheath. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. If they must go through a gate or doorway containing this type of device, patients should turn off their generator and proceed with caution, being sure to move through the device quickly. Implantation of multiple leads. **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. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Keep dry to avoid damage. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Exposure to body fluids or saline. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Keep the device dry. 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. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Object Info: - MRI Safety Implantation of two systems. 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. Approved models and implant locations for an MR Conditional lead-only system. Excessive lead migration may require reoperation to replace the leads. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Removing each item in slow movements while holding the remaining components in place will assist this process. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Explosive and flammable gasses. Wireless use restrictions. Interference with wireless equipment. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Patient activities and environmental precautions. 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. 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. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Pregnancy and nursing. 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. Lead handling. Abbott's Proclaim XR Spinal Cord Stimulation System Now - Insider 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. 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. Wireless use restrictions. Storage environment. Scuba diving or hyperbaric chambers. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Surgical complications and adverse events may be more frequent and severe in patients with diabetes. six to eight weeks after implantation of a neurostimulation system. Unauthorized changes to stimulation parameters. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Infections may require that the device be explanted. Stimulation effectiveness. Remove leads slowly (at a suggested rate of 1 cm/s while holding the lead between the thumb and forefinger) to avoid breaking the lead and leaving fragments in the patient. Handle the device with care. 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. 21 CR 801.109(b) The label of the device, other than surgical instruments, bears: (1) The symbol statement Rx only or only or the statement Caution: Federal law restricts this device to sale by or on the order of a ___, the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and. Implanting physicians should be experienced in stereotactic and functional neurosurgery. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. 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. Security, antitheft, and radiofrequency identification (RFID) devices. 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. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. If unpleasant sensations occur, the IPG should be turned off immediately. Pain is not resolved. FDA approves new MRI compatibility for Abbott's Proclaim spinal cord Number of leads implanted. Additional Disadvantages. While charging the generator, patients may perceive an increase in temperature at the generator site. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Do not use surgical instruments to handle the lead. 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. 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). Avoid placing equipment components directly over other electronic devices. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Back pain. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Application modification. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. If two systems are implanted, ensure that at least 20 cm (8 in.) Learn more about the scan details for our MR Conditional products below. Implantation at vertebral levels above T10. Patient training. Implantation of multiple leads. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. 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). Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. 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 and induce voltage through the lead that could jolt or shock the patient. Disadvantages and Risks of Spinal Cord Stimulation If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. 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. Sheath rotation. 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. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Postural changes. Do not crush, puncture, or burn the IPG because explosion or fire may result. Therapeutic radiation. External defibrillators. Neurosurgery Pain Management Orthopaedic Surgery Component manipulation. Electrical medical treatment. However, some patients may experience a decrease or increase in the perceived level of stimulation. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Lead movement. Always perform removal with the patient conscious and able to give feedback. Application modification. 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. Anchoring leads. Diathermy therapy. Keep programmers and controllers dry. Using the tunneling tool. 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. Patients should cautiously approach such devices and should request help to bypass them. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. When multiple leads are implanted, route the lead extensions so the area between them is minimized. IPGs contain batteries as well as other potentially hazardous materials. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. maximize the distance between the implanted systems; Use in patients with diabetes. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. Return all explanted components to Abbott Medical for safe disposal. All components listed must be implanted unless noted as "optional." Reducing the Pains of Chronic Pain Treatment | Abbott Newsroom Failure to do so may result in damage to the sheath. 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. Infections related to system implantation might require that the device be explanted. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving.