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. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Stimulation effectiveness. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. The Eterna SCS 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. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Lead movement. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. Placement of lead connection in neck. 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. Computed tomography (CT). Do not use the system if the use-before date has expired. Exit Surgery mode during intraoperative testing and after the procedure is completed. 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. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Wireless use restrictions. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. If needed, return the equipment to Abbott Medical for service. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) 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. This includes oxygen-enriched environments such as hyperbaric chambers. Do not use excessive pressure when injecting through the sheath. 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), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). Interference with other devices. Package or component damage. IPGs contain batteries as well as other potentially hazardous materials. Clinician programmers, patient controllers, and chargers are not waterproof. Mobile phones. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Read this section to gather important prescription and safety information. 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. Select patients appropriately for deep brain stimulation. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. 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. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. The equipment is not serviceable by the customer. Recharge-by date. Devices with one-hour recharge per day. 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. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. 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). Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Back pain. 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. Electromagnetic interference (EMI). Excessive lead migration may require reoperation to replace the leads. To prevent injury or damage to the system, do not modify the equipment. Failure to do so may result in difficulty delivering the lead. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. 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. Handle the programmers and controllers with care. 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.**. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). A recharge-by date is printed on the packaging. 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. Return all explanted components to Abbott Medical for safe disposal. 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. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. However, some patients may experience a decrease or increase in the perceived level of stimulation. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Number of leads implanted. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Set the electrosurgery device to the lowest possible energy setting. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Patients who are unable to properly operate the system. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. High-output ultrasonics and lithotripsy. Stabilizing the lead during insertion. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated. 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. Anchoring leads. 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 severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. 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. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. 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. 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 . 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. Implantation of two systems. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. The force of the instruments may damage the lead or stylet. Return the explanted IPG to Abbott Medical. Patient selection. 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. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. Therapeutic radiation. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. The clinician programmer and patient controller are not waterproof. Storage environment. (2) The method of its application or use. Return any suspect components to Abbott Medical for evaluation. Explosive and flammable gasses. Coagulopathies. Remove the stylet from the lead only when satisfied with lead placement. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Generators contain batteries as well as other potentially hazardous materials. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. Do not crush, puncture, or burn these devices because explosion or fire may result. 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. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Have the patient check the device for proper functioning, even if the device was turned off. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. 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. Return any suspect components to Abbott Medical for evaluation. The Proclaim XR SCS system can provide relief to . Stimulation Modes. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Neurosurgery Pain Management Orthopaedic Surgery Approved models and implant locations for an MR Conditional lead-only system. Physicians should also discuss any risks of MRI with patients. To prevent injury or damage to the system, do not modify the equipment. 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. 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. Device components. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Consumer goods and electronic devices. Do not crush, puncture, or burn the IPG because explosion or fire may result. 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. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. If patients feel that the TENS device may be interfering with the neurostimulator, patients should discontinue using the TENS device until they talk with their physician. Failure to do so may cause harm to the patient such as damage to the dura. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Safety Info ID# Safety Topic / Subject Article Text 294: Spinal Cord Stimulation Systems: St. Jude Medical: Genesis, GenesisXP, GenesisRC, Eon, Eon C, Eon Mini, and Renew The Genesis, GenesisXP, GenesisRC, Eon, EonC, Eon Mini, and Renew neuromodulation devices (St. Jude Medical) used for spinal cord stimul. Output power below 80 W is recommended for all activations. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. Failure to do so can damage or cut the lead or sheath. 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 Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Poor surgical risks. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Implanted cardiac systems. Implantation of two systems. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. 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. 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. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. 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. 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. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Confirm that no adverse conditions to MR scanning are present. Use extreme care when handling system components prior to implantation. Control of the patient controller. 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. 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. Securing the lead with the lead stabilizer will mitigate this risk. Unauthorized changes to stimulation parameters. Scuba diving or hyperbaric chambers. 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). Wireless use restrictions. 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. Preventing infection. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. Inserting the anchor. 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. Radiofrequency or microwave ablation. Skydiving, skiing, or hiking in the mountains. Infections related to system implantation might require that the device be explanted. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Transcutaneous electrical nerve stimulation (TENS). The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Advise patients about adverse effects. Device modification. Failure to provide strain relief may result in lead migration requiring a revision procedure. Inaccurate ECG results may lead to inappropriate treatment of the patient. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Patient activities and environmental precautions. INDICATIONS FOR USE Electrosurgery. 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. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. If multiple leads are implanted, leads and extensions should be routed in close proximity. Always perform removal with the patient conscious and able to give feedback. Do not use the application if the operating system is compromised (that is, jailbroken). 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. 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. 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. After defibrillation, confirm the neurostimulation system is still working. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. 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. 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. Patients should cautiously approach such devices and should request help to bypass them. Sheath insertion precaution. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. To prevent unintended stimulation, do not modify the operating system in any way. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. 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). No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Schu S, Gulve A, ElDabe S, et al. Unwanted changes in stimulation may include a jolting or shocking feeling. Programmer and controller devices are not waterproof. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Return all explanted IPGs to Abbott Medical for safe disposal. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor.