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Physicians should also discuss any risks of MRI with patients. 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. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 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. High stimulation outputs. 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. 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. IPGs contain batteries as well as other potentially hazardous materials. Explosive and flammable gasses. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Inserting the anchor. Radiofrequency or microwave ablation. Keep programmers and controllers dry. Advise patients about adverse effects. 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 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. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. 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. To prevent unintended stimulation, do not modify the operating system in any way. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Lead movement. Free from the hassles of recharging. System testing. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Deep brain stimulation complications include, but are not limited to, the following: Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture, Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture, Initial jolt or tingling during stimulation; jolting or shocking sensations, Lead fracture, migration, or dislodgement, Extension malfunction, fracture, or disconnect, Deep brain stimulation system failure or battery failure within the device, Deep brain stimulation system malfunction or dislodgement, Allergic or rejection response to implanted materials, Persistent pain, tightness, or redness at the incision sites or general pain, General erosion or local skin erosion over the IPG, Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck), Impaired wound healing (e.g., incision site drainage) or abscess formation, Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component, Stimulation-related complications or other complications, Worsening of motor impairment and Parkinsons disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia, Paresis, asthenia, hemiplegia, or hemiparesis, Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance, Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia, Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium, Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope), Eye disorder including eye apraxia or blepharospasm, (1) The symbol statement Rx only or only or the statement Caution: Federal law restricts this device to sale by or on the order of a ___, the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Return all explanted generators to Abbott Medical for safe disposal. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. 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. Electrical medical treatment. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. The system is intended to be used with leads and associated extensions that are compatible with the system. The clinician programmer and patient controller are not waterproof. 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. The placement of the leads involves some risk, as with any surgical procedure. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Confirm the neurostimulation system is functioning correctly after the procedure. Patient's visual ability to read the patient controller screen. 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. 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. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. 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. The website that you have requested also may not be optimized for your screen size. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Implantation of two systems. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. Proclaim XR SCS System Meaningful relief from chronic pain. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Placing the IPG. 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. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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 . 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. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. However, some patients may experience a decrease or increase in the perceived level of stimulation. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. IPG disposal. Store components and their packaging where they will not come in contact with liquids of any kind. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Operation of machines, equipment, and vehicles. 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. Our Invisible Trial System TM is a discreet, app . Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. 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. If lithotripsy must be used, do not focus the energy near the IPG. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Mobile phones. 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. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Do not use the application if the operating system is compromised (i.e., jailbroken). 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. Return of symptoms and rebound effect. If multiple leads are implanted, leads and extensions should be routed in close proximity. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Neuromodulation. Removing components. Do not use excessive pressure when injecting through the sheath. 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. IPG placement. Conditional 5. Implant heating. Stimulation effectiveness. If two systems are implanted, ensure that at least 20 cm (8 in.) This includes oxygen-enriched environments such as hyperbaric chambers. Application modification. Postural changes. Stabilizing the lead during insertion. If the stylet is removed from the lead, it may be difficult to reinsert it. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. The following warnings apply to this neurostimulation system. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Lead movement. To prevent injury or damage to the system, do not modify the equipment. 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. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Single-use, sterile device. To prevent unintended stimulation, do not modify the generator software in any way. 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. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. 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. Anchoring leads. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Electromagnetic interference (EMI). During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). Storage environment. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. Device modification. High-output ultrasonics and lithotripsy. Lead movement. The following precautions apply to this neurostimulation system. This equipment is not serviceable by the customer. Securing the IPG. IPGs 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). The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Follow proper infection control procedures. Scuba diving or hyperbaric chambers. 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. High stimulation outputs. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. 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. Pediatric use. Implantation at vertebral levels above T10. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. 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. This neurostimulation system is contraindicated for patients who are. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Overcommunicating with the IPG. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) 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. Lead inspection. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Other active implantable devices. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. Clinician programmers, patient controllers, and chargers are not waterproof. 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. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Wireless use restrictions. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. 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. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Always be aware of the needle tip position. 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. Electromagnetic interference (EMI). Scuba diving and hyperbaric chambers. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. 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. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Skydiving, skiing, or hiking in the mountains. Multiple leads. Patients should cautiously approach such devices and should request help to bypass them. Battery care. Device modification. High-output ultrasonics and lithotripsy. Follow proper infection control procedures. Use appropriate sterile technique when implanting leads and the IPG. Application modification. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.