Use appropriate sterile technique when implanting leads and the IPG. The device should be turned off and the doctor contacted if this occurs. 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. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Devices with one-hour recharge per day. Keep the device dry. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Up to two leads, lead protection boots, and burr hole covers may be implanted. 2013;16(5):471-482. Implantation of multiple leads. 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. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Using surgical instruments. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Security, antitheft, and radiofrequency identification (RFID) devices. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Pediatric use. Application modification. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, 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, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. Lead movement. 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. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Return any suspect components to Abbott Medical for evaluation. *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. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Do not use excessive pressure when injecting through the sheath. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Securing the anchor. ); 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. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Single-use, sterile device. 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. FDA approves new MRI compatibility for Abbott's Proclaim spinal cord Damage to the system may not be immediately detectable. 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. Do not crush, puncture, or burn the generator because explosion or fire may result. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. High-output ultrasonics and lithotripsy. Store components and their packaging where they will not come in contact with liquids of any kind. 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 Do not use the application if the operating system is compromised (that is, jailbroken). In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Do not use the system if the use-before date has expired. Only apply software updates that are published directly by Abbott Medical. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). INDICATIONS FOR USE 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). Explosive and flammable gasses. Infection. 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. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. 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. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. 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. If lithotripsy must be used, do not focus the energy near the IPG. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . The tip of the sheath may whip around and could cause harm to the patient. IPGs contain batteries as well as other potentially hazardous materials. 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. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Consumer goods and electronic devices. Exit Surgery mode during intraoperative testing and after the procedure is completed. 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. Coagulopathies. ), 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.). Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. Therapeutic radiation. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). 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. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Additional Disadvantages. If lithotripsy must be used, do not focus the energy near the generator. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Patients should cautiously approach such devices and should request help to bypass them. Unwanted changes in stimulation may include a jolting or shocking feeling. Excessive lead migration may require reoperation to replace the leads. If needed, return the equipment to Abbott Medical for service. Set the electrosurgery device to the lowest possible energy setting. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). Patient's visual ability to read the patient controller screen. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. 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. Handle the programmers and controllers with care. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Providing strain relief. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. 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. Number of leads implanted. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Confirm that no adverse conditions to MR scanning are present. Keep them dry to avoid damage. Storage environment. Use extreme care when handling system components. If unpleasant sensations occur, the IPG should be turned off immediately. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Transcutaneous electrical nerve stimulation (TENS). maximize the distance between the implanted systems; Use in patients with diabetes. 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. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Loss of coordination is a potential side effect of DBS therapy. To prevent injury or damage to the system, do not modify the equipment. Store components and their packaging where they will not come in contact with liquids of any kind. Follow proper infection control procedures. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Damage to the system may not be immediately detectable. Patient selection. 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. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Return all explanted components to Abbott Medical for safe disposal. Scuba diving and hyperbaric chambers. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. When multiple leads are implanted, route the lead extensions so the area between them is minimized. 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. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. 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 Security, antitheft, and radiofrequency identification (RFID) devices. Select patients appropriately for deep brain stimulation. Patients should cautiously approach such devices and should request help to bypass them. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Caution patients to not make unauthorized changes to physician-established stimulation parameters. In rare cases, this can create a medical emergency. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). If unpleasant sensations occur, turn off stimulation immediately. Back pain. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Keep dry to avoid damage. Electrical medical treatment. Magnetic resonance imaging (MRI). 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). Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) If the patient requires a CT scan, all stimulation should be turned off before the procedure. 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. Remove leads slowly. Return any suspect components to Abbott Medical for evaluation. Do not crush, puncture, or burn these devices because explosion or fire may result. High stimulation outputs. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. 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. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Patients should be advised to not use therapeutic magnets. 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 . 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. Pregnancy and nursing. IMAGINE A FUTURE - cloud.neuroemail.abbott.com Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Thorough psychiatric screening should be performed. Infections may require that the device be explanted. Operation of machines, equipment, and vehicles. Wireless use restrictions. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Restricted areas. Diathermy is further prohibited because it may also damage the neurostimulation system components. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Read this section to gather important prescription and safety information. To prevent injury or damage to the system, do not modify the equipment. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. Confirm the neurostimulation system is functioning correctly after the procedure. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinsons disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI. Implantation of two systems. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Failure to do so can damage or cut the lead or sheath. 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. The Proclaim TM SCS System is also the first upgradeable and recharge-free spinal cord stimulation system capable of delivering both tonic stimulation and Abbott's proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Patient selection. Ensure the patients neurostimulation system is in MRI mode. Wireless communications equipment, such as mobile and cordless phones and walkie-talkies, may interfere with the IPG if the equipment gets too close to the IPG. Avoid programming either device in a unipolar mode (using the devices can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. 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. Storage environment. Generators contain batteries as well as other potentially hazardous materials. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Equipment is not serviceable by the customer. Wireless use restrictions. 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. The equipment is not serviceable by the customer. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Bending the sheath. Implantation at vertebral levels above T10. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. 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. Interference with wireless equipment. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Placing the IPG. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Patients should cautiously approach such devices and should request help to bypass them. If lithotripsy must be used, do not focus the energy near the IPG. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Component disposal. High stimulation outputs. With the Proclaim XR SCS system, you can have hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings* without ever needing to charge the system. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. Always be aware of the needle tip position. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Instructions for Use Website - SJM Lead damage from tools. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. THE List - MRI Safety After defibrillation, confirm the neurostimulation system is still working. 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. Some of this systems electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. 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 suture directly onto the lead to avoid damaging the lead. Infection. Electrosurgery. To prevent unintended stimulation, do not modify the operating system in any way. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. External defibrillators. For more information, see the clinician programmer manual. Do not use surgical instruments to handle the lead. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Disadvantages and Risks of Spinal Cord Stimulation Anchoring leads. Keep them dry to avoid damage. Computed tomography (CT). The clinician programmer and patient controller are not waterproof. The U.S. Food and Drug Administration (FDA) has approved Abbott 's request to expand the magnetic resonance imaging (MRI) compatibility with its Proclaim XR spinal cord stimulation system with . Approved models and implant locations for an MR Conditional lead-only system. 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.
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