Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Securing the lead with the lead stabilizer will mitigate this risk. Ensure the patients neurostimulation system is in MRI mode. 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. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. 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. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. 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. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. 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 . Do not crush, puncture, or burn the IPG because explosion or fire may result. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Always be aware of the needle tip position. Keep them dry to avoid damage. 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. 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. Patients should cautiously approach such devices and should request help to bypass them. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Exposure to body fluids or saline. Preventing infection. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. 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 . Read this section to gather important prescription and safety information. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Product materials. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. External defibrillators. Poor surgical risks. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. 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. Device modification. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Battery precaution. 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. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Do not crush, puncture, or burn the generator because explosion or fire may result. Free from the hassles of recharging. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. If unpleasant sensations occur, turn off stimulation immediately. 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. Scuba diving or hyperbaric chambers. 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. 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. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Patient selection. 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. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. Confirm that no adverse conditions to MR scanning are present. FDA's expanded . Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Keep them dry to avoid damage. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Application modification. 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. Removing each item in slow movements while holding the remaining components in place will assist this process. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Risk of depression, suicidal ideations, and suicide. Component manipulation by patients. 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. Store components and their packaging where they will not come in contact with liquids of any kind. Interference with wireless equipment. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Operation of machinery and equipment. Remove the stylet from the lead only when satisfied with lead placement. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. 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 Approved models and implant locations for an MR Conditional lead-only system. Do not use the application if the operating system is compromised (that is, jailbroken). Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Devices with one-hour recharge per day. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Component manipulation by patient. If multiple leads are implanted, leads and extensions should be routed in close proximity. Conscious sedation during removal. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Do not use surgical instruments to handle the lead. Stimulation effectiveness. Lead movement. Electrical medical treatment. Do not use the application if the operating system is compromised (i.e., jailbroken). Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your generator immediately.). Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. 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. 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. Avoid excessive stimulation. away from the generator and avoid placing any smart device in a pocket near the generator. Failure to do so may result in damage to the sheath. 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. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Removing a kinked sheath. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. When multiple leads are implanted, route the lead extensions so the area between them is minimized. 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. 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. Electrosurgery. 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. 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). Learn more about the scan details for our MR Conditional products below. Case damage. Long-term safety and effectiveness. Additional Disadvantages. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. The system is intended to be used with leads and associated extensions that are compatible with the system. Diathermy is further prohibited because it may also damage the neurostimulation system components. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. The equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Advance the needle and guidewire slowly. *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. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Skydiving, skiing, or hiking in the mountains. 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,. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. The website that you have requested also may not be optimized for your screen size. Infection. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Return all explanted components to Abbott Medical for safe disposal. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in a severe injury or death. Return any suspect components to Abbott Medical for evaluation. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Infections related to system implantation might require that the device be explanted. Insertion of a sheath without the lead may result in dural puncture. 2013;16(5):471-482. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. This neurostimulation system is contraindicated for patients who are. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Application modification. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. 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. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. 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. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 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. Loss of coordination is a potential side effect of DBS therapy. External defibrillators. 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. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS systems(available online atmedical.abbott/manuals). Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). 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. 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. Patients who are unable to properly operate the system. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Poor surgical risks. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Do not resterilize or reimplant an explanted system for any reason. High-output ultrasonics and lithotripsy. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. 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. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. It is extremely important to select patients appropriately for neurostimulation. 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. Follow proper infection control procedures. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. 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. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. 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). Component handling. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. 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. 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.
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