abbott proclaim spinal cord stimulator mri safety

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 at medical.abbott/manuals). Neurostimulation systems have materials that come in contact or may come in contact with tissue. Abbott - Spinal Cord Stimulation 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. Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Return any suspect components to Abbott Medical for evaluation. 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. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Lasting Relief through our smallest system yet. 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. 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. 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. Read this section to gather important prescription and safety information. 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). Diathermy is further prohibited because it may also damage the neurostimulation system components. If two systems are implanted, ensure that at least 20 cm (8 in.) 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. 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). FDA's expanded . 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. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. 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). 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. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. THE List - MRI Safety IPG placement. Return the explanted IPG to Abbott Medical. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. Always perform removal of implanted components with the patient conscious and able to give feedback. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. After defibrillation, confirm the neurostimulation system is still working. High stimulation outputs. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. 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. Loss of coordination is a potential side effect of DBS therapy. Exit Surgery mode during intraoperative testing and after the procedure is completed. If lithotripsy must be used, do not focus the energy near the IPG. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. 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. Postural changes. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. 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. Confirm that no adverse conditions to MR scanning are present. Pain is not resolved. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. See Full System Components below if the patient has an IPG and extensions implanted. Computed tomography (CT). Operation of machines, equipment, and vehicles. Return all explanted components to Abbott Medical for safe disposal. Store components and their packaging where they will not come in contact with liquids of any kind. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. communication equipment (such as microwave transmitters and high-power amateur transmitters). Conditional 5. Implantation at vertebral levels above T10. Needle positioning. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Advance the needle and guidewire slowly. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Damage to the system may not be immediately detectable. 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 contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Our Invisible Trial System TM is a discreet, app . Removing components. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Do not crush, puncture, or burn these devices because explosion or fire may result. 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. If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. The placement of the leads involves some risk, as with any surgical procedure. Physicians should also discuss any risks of MRI with patients. Using surgical instruments. Securing the anchor. Remove the stylet from the lead only when satisfied with lead placement. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. If unpleasant sensations occur, the device should be turned off immediately. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. Have the patient check the device for proper functioning, even if the device was turned off. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . 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. Anchoring leads. Skin erosion. Magnetic resonance imaging (MRI). This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Surgical advice for removal. Wireless use restrictions. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Physicians should also discuss any risks of MRI with patients. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. 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. away from the generator and avoid placing any smart device in a pocket near the generator. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. High-output ultrasonics and lithotripsy. Electromagnetic interference (EMI). If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Case damage. Patients should cautiously approach such devices and should request help to bypass them. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. Pregnancy and nursing. Lead insertion through sheath. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. 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. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Do not resterilize or reimplant an explanted system for any reason. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. The following precautions apply to this neurostimulation system. Electrosurgery. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. 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. 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. Patient training. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. 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. PATIENTS Return any suspect components to Abbott Medical for evaluation. Stimulation effectiveness. All components listed must be implanted unless noted as "optional." 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. Single-use, sterile device. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Explosive or flammable gasses. Lead movement. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Patients should cautiously approach such devices and should request help to bypass them. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Scanning under different conditions may cause device malfunction, severe patient injury, or death. The clinician programmer and patient controller are not waterproof. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Application modification. *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. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. FDA Expands MRI Compatibility With Spinal Stimulation for Pain Ensure the patients neurostimulation system is in MRI mode. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS This includes oxygen-enriched environments such as hyperbaric chambers. If two systems are implanted, ensure that at least 20 cm (8 in.) If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Return all explanted components to Abbott Medical for safe disposal. 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. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Follow proper infection control procedures. Store components and their packaging where they will not come in contact with liquids of any kind. 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. 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. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. Patients who are unable to properly operate the system. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. The effect of mobile phones on deep brain stimulation is unknown. Device modification. This neurostimulation system is contraindicated for patients who are. External defibrillators. away from the generator and avoid placing any smart device in a pocket near the generator. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. 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. Use care when reinserting a stylet. Programmer and controller devices are not waterproof. 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. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Infections related to system implantation might require that the device be explanted. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving.