Patients should not use this neurostimulation system if they are pregnant or nursing. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Return them to Abbott Medical for proper disposal. Do not use the application if the operating system is compromised (that is, jailbroken). Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur. The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Abbott - Spinal Cord Stimulation Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. IPGs contain batteries as well as other potentially hazardous materials. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. 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. Implantation of two systems. Free from the hassles of recharging. Do not crush, puncture, or burn the IPG because explosion or fire may result. Radiofrequency or microwave ablation. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Application modification. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Explosive and flammable gasses. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Do not crush, puncture, or burn the generator because explosion or fire may result. 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. 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. Implant heating. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Therapeutic radiation. Detailed information on storage environment is provided in the appendix of this manual. Programmer use. The system is intended to be used with leads and associated extensions that are compatible with the system. Up to two leads, lead protection boots, and burr hole covers may be implanted. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Patients should cautiously approach such devices and should request help to bypass them. Application modification. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Keep them dry to avoid damage. Scuba diving and hyperbaric chambers. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Therapeutic radiation. Do not crush, puncture, or burn these devices because explosion or fire may result. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Spinal Cord Stimulator Systems - Boston Scientific 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. Always be aware of the needle tip position. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. 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. 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. Keep dry to avoid damage. Cremation. Ultrasonic scanning equipment. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. To prevent unintended stimulation, do not modify the operating system in any way. Use appropriate sterile technique when implanting leads and the IPG. 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. 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. Battery precaution. Inaccurate ECG results may lead to inappropriate treatment of the patient. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. Generators contain batteries as well as other potentially hazardous materials. 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). Pediatric use. If needed, return the equipment to Abbott Medical for service. 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. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Skin erosion. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. 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. 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. Consumer goods and electronic devices. Handle the device with care. If needed, return the equipment to Abbott Medical for service. 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. Proclaim DRG System | Abbott Case damage. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. 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. Single-use, sterile device. High stimulation outputs. 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 severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. The Proclaim XR SCS system can provide relief to . Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Clinician training. This includes oxygen-enriched environments such as hyperbaric chambers. 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). Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Insertion of a sheath without the lead may result in dural puncture. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Securing the lead with the lead stabilizer will mitigate this risk. Do not use surgical instruments to handle the lead. Component disposal. Placing the IPG. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. Lead movement. 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. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. 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. Electrosurgery. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. 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. 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. Confirm that no adverse conditions to MR scanning are present. Instructions for Use Website - SJM Sheath insertion precaution. Poor surgical risks. 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. 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. 2013;16(5):471-482. 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 should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. Keep programmers and controllers dry. Patients should be advised to not use therapeutic magnets. It is extremely important to select patients appropriately for neurostimulation. Stimulation Modes. Damage to the system may not be immediately detectable. Diathermy is further prohibited because it may also damage the neurostimulation system components. Sheath rotation. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted 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. 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. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. ); 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. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Infections related to system implantation might require that the device be explanted. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. 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. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. 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. separates the implanted IPGs to minimize unintended interaction with other system components. Follow proper infection control procedures. Surgeon training. Advancing components. Disadvantages and Risks of Spinal Cord Stimulation 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. 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. 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. Package or component damage. Diathermy is further prohibited because it may also damage the neurostimulation system components. Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Patients should avoid charging their generator over an incision that has not completely healed. Consumer goods and electronic devices. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. 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. Stimulation effectiveness. 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. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Keep them dry to avoid damage. The effect of mobile phones on deep brain stimulation is unknown. The IPG should be explanted before cremation because the IPG could explode.