MR safety: spinal cord stimulators - Questions and Answers in MRI This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Needle positioning. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Follow proper infection control procedures. Radiofrequency or microwave ablation. Do not crush, puncture, or burn the IPG because explosion or fire may result. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Loss of coordination is a potential side effect of DBS therapy. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Keep programmers and controllers dry. Consumer goods and electronic devices. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Anchoring leads. Stimulation effectiveness has been established for one year. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Wireless use restrictions. Damage to shallow implants. 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. If unpleasant sensations occur, turn off stimulation immediately. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. High-output ultrasonics and lithotripsy. 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. separates the implanted generators to minimize unintended interaction with other system components. Avoid placing equipment components directly over other electronic devices. 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. 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. 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. External defibrillators. 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. Read this section to gather important prescription and safety information. Neuromodulation. Bending the sheath. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Do not use the application if the operating system is compromised (that is, jailbroken). If a system does not meet the MR Conditional requirements, consider it MR Unsafe. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Always perform removal of implanted components with the patient conscious and able to give feedback. Activities requiring coordination. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. 21 CR 801.109(b) The label of the device, other than surgical instruments, bears: (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. If unpleasant sensations occur, the device should be turned off immediately. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Electrocardiograms. 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. To find Shipping Material Packaging Waste information, select Healthcare Professionals. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Patients should cautiously approach such devices and should request help to bypass them. Security, antitheft, and radiofrequency identification (RFID) devices. Use care when reinserting a stylet. 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. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. 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. Operation of machines, equipment, and vehicles. Device profile of the Proclaim XR neurostimulation system for the Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. 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. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). See Full System Components below if the patient has an IPG and extensions implanted. 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. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Care and handling of components. Placing the IPG. 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 all explanted components to Abbott Medical for safe disposal. away from the generator and avoid placing any smart device in a pocket near the generator. Radiofrequency or microwave ablation. Use appropriate sterile technique when implanting leads and the IPG. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Patients should cautiously approach such devices and should request help to bypass them. 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. 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. Implanting physicians should be experienced in stereotactic and functional neurosurgery. 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 . Use extreme care when handling system components prior to implantation. 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. Remove leads slowly. 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. Programmer and controller devices are not waterproof. Lead movement. Failure to do so may result in damage to the sheath. 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. 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. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. 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 system is intended to be used with leads and associated extensions that are compatible with the system. Magnetic resonance imaging (MRI). If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Operation of machinery and equipment. Other active implantable devices. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. External defibrillators. To prevent injury or damage to the system, do not modify the equipment. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. If needed, return the equipment to Abbott Medical for service. If needed, return the equipment to Abbott Medical for service. Infections related to system implantation might require that the device be explanted. Implantation of two systems. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. 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. Lead inspection. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. 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. Our Invisible Trial System TM is a discreet, app . The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Advancing components. 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. 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. Implantation of two systems. Pediatric use. Patients should cautiously approach such devices and should request help to bypass them. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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. Programmer use. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Follow proper infection control procedures. The effect of mobile phones on deep brain stimulation is unknown. Exposure to body fluids or saline. If unpleasant sensations occur, the IPG should be turned off immediately. Inserting the anchor. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Single-use, sterile device. 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. Place the neurostimulator in Surgery mode before using an electrosurgery device. Do not use surgical instruments to handle the lead. Output power below 80 W is recommended for all activations. Multiple leads. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). 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. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Keep them dry to avoid damage. 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. 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. 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. 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. Keep dry to avoid damage. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. 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. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Patient selection. 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 two systems are implanted, ensure that at least 20 cm (8 in.) Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Security, antitheft, and radiofrequency identification (RFID) devices. Clinician training. 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. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. Store components and their packaging where they will not come in contact with liquids of any kind. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. ** Application modification. 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. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Diathermy is further prohibited because it may also damage the neurostimulation system components. Use extreme care when handling system components. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Thorough psychiatric screening should be performed. 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. System testing. Approved models and implant locations for an MR Conditional lead-only system. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Placement of lead connection in neck. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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). PDF View Shellock R & D Services, Inc. email: . Infection. 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. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Providing strain relief. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Explosive or flammable gasses. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. Device components. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Risk of depression, suicidal ideations, and suicide. 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. The website that you have requested also may not be optimized for your screen size. 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 neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Exit Surgery mode during intraoperative testing and after the procedure is completed. Sheath rotation. Operation of machines, equipment, and vehicles. To prevent injury or damage to the system, do not modify the equipment. 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. 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. Disadvantages and Risks of Spinal Cord Stimulation The following warnings apply to this neurostimulation system. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Do not suture directly onto the lead to avoid damaging the lead. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. Patient selection. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Devices with one-hour recharge per day. Bathing. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Learn more about the scan details for our MR Conditional products below. Security, antitheft, and radiofrequency identification (RFID) devices. Number of leads implanted. The tip of the sheath may whip around and could cause harm to the patient. The device should be turned off and the doctor contacted if this occurs. Always perform removal with the patient conscious and able to give feedback. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. Pediatric use. Do not use excessive pressure when injecting through the sheath. Electrosurgery. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Keep the device dry. Sheath retraction. Failure to do so may result in difficulty delivering the lead. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device.