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.**. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Inserting the anchor. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Placement of lead connection in neck. Placing the IPG. Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . Proclaim XR SCS System Meaningful relief from chronic pain. Unauthorized changes to stimulation parameters. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. away from the generator and avoid placing any smart device in a pocket near the generator. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. 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. 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. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. 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. MR safety: spinal cord stimulators - Questions and Answers in MRI Device components. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. 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. 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. Stimulation effectiveness has been established for one year. Storage environment. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). Diathermy therapy. Avoid placing equipment components directly over other electronic devices. 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. External defibrillators. 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 at medical.abbott/manuals). For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Magnetic resonance imaging (MRI). (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Explosive or flammable gasses. Use extreme care when handling system components prior to implantation. Postural changes. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Have the patient check the device for proper functioning, even if the device was turned off. Implant heating. 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.). Do not use excessive pressure when injecting through the sheath. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. Implantation of multiple leads. All components listed must be implanted unless noted as "optional." Implantation of two systems. Use appropriate sterile technique when implanting leads and the IPG. Single-use, sterile device. Device modification. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Store components and their packaging where they will not come in contact with liquids of any kind. Always perform removal with the patient conscious and able to give feedback. 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. Stimulation effectiveness. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. 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). 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,. Patients should cautiously approach such devices and should request help to bypass them. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Activities requiring excessive twisting or stretching. Scuba diving or hyperbaric chambers. Using surgical instruments. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. 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. Handle the device with care. To prevent injury or damage to the system, do not modify the equipment. Clinician training. 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. Conscious sedation. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Stimulation Modes. IPG disposal. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. To prevent unintended stimulation, do not modify the operating system in any way. Return of symptoms and rebound effect. Implantation at vertebral levels above T10. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Infections related to system implantation might require that the device be explanted. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. *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. Confirm the neurostimulation system is functioning correctly after the procedure. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. To prevent injury or damage to the system, do not modify the equipment. Storage environment. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott Lead inspection. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. Device modification. Safety and effectiveness of neurostimulation for pediatric use have not been established. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. If lithotripsy must be used, do not focus the energy near the IPG. MRI Support | Abbott Neuromodulation Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Scuba diving and hyperbaric chambers. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Sheath insertion warning. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). Instructions for Use Website - SJM Devices with one-hour recharge per day. If lithotripsy must be used, do not focus the energy near the IPG. Package or component damage. Wireless use restrictions. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. Up to two leads, lead protection boots, and burr hole covers may be implanted. Lead damage from tools. 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. Damage to the system may not be immediately detectable. Control of the patient controller. Operating the device near gas fumes or vapors could cause them to catch fire. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Poor surgical risks. 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). Lead movement. Physicians should also discuss any risks of MRI with patients. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Infections related to system implantation might require that the device be explanted. Advise patients about adverse effects. 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. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. PATIENTS Only apply software updates that are published directly by Abbott Medical. Do not crush, puncture, or burn these devices because explosion or fire may result. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Restricted areas. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Read this section to gather important prescription and safety information. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. Surgical advice for removal. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. 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. Keep them dry to avoid damage. 2013;16(5):471-482. 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. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Transcutaneous electrical nerve stimulation (TENS). Free from the hassles of recharging. PDF View Shellock R & D Services, Inc. email: . If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Radiofrequency or microwave ablation. Implantation of two systems. Bathing. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. 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. Anchoring leads. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Surgeon training. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Infections may require that the device be explanted. 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. The tip of the sheath may whip around and could cause harm to the patient. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Pediatric use. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Always be aware of the needle tip position. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. If needed, return the equipment to Abbott Medical for service. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. Consumer goods and electronic devices. Sheath retraction. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Keep dry to avoid damage. (2) The method of its application or use. The system is intended to be used with leads and associated extensions that are compatible with the system. While charging the generator, patients may perceive an increase in temperature at the generator site. Excessive lead migration may require reoperation to replace the leads. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Cremation. Wireless use restrictions. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Needle insertion. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Object Info: - MRI Safety 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. Patient training. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Patient training. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Exposure to body fluids or saline. However, some patients may experience a decrease or increase in the perceived level of stimulation. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. The safety and efficacy of the implantation of greater than four leads have not been evaluated. 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. Neurostimulation should not be used on patients who are poor surgical candidates. Care and handling of components. Do not crush, puncture, or burn the IPG because explosion or fire may result. Lead movement. Infection. Lead movement. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. MRI Support | Abbott Nerve damage may result from traumatic or surgical nerve injury. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Do not crush, puncture, or burn the generator because explosion or fire may result. 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. Lead movement. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Security, antitheft, and radiofrequency identification (RFID) devices. Operation of machines, equipment, and vehicles. THE List - MRI Safety Explosive and flammable gasses. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Scuba diving or hyperbaric chambers. Return all explanted IPGs to Abbott Medical for safe disposal. 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. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. 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.
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