Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Computed tomography (CT). 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Patients should avoid charging their generator over an incision that has not completely healed. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. The system is intended to be used with leads and associated extensions that are compatible with the system. 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. Read this section to gather important prescription and safety information. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. 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. See Full System Components below if the patient has an IPG and extensions implanted. Clinician training. 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. Pediatric use. 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. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Providing strain relief. If interference occurs, try holding the phone to the other ear or turning off the phone. If unpleasant sensations occur, turn off stimulation immediately. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 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 (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Damage to the system may not be immediately detectable. Wireless use restrictions. Patients should cautiously approach such devices and should request help to bypass them. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. 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). 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. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. The safety and effectiveness of neurostimulation for pediatric use have not been established. Therapeutic radiation. If lithotripsy must be used, do not focus the energy near the IPG. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Abandoned leads and replacement leads. 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. Always be aware of the needle tip position. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. 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. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Follow proper infection control procedures. In rare cases, this can create a medical emergency. The placement of the leads involves some risk, as with any surgical procedure. Diathermy therapy. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Do not use excessive pressure when injecting through the sheath. 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. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. 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. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. 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. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. 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. Programmer and controller devices are not waterproof. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Lead movement. Return any suspect components to Abbott Medical for evaluation. Safety and effectiveness of neurostimulation for pediatric use have not been established. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Operation of machinery and equipment. Lead movement. Needle insertion. Implantation of multiple leads. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. 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. Handle the device with care. 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). 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. ), 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 or breakage, Stimulation in unwanted places (such as stimulation of the chest wall), Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space Cerebrospinal fluid (CSF) leakage, Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, Pain or bleeding where the needle was inserted, Seroma (mass or swelling) at the implant site, Allergic or rejection response to device or implant materials, Hardware malfunction that requires replacing the neurostimulator, Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain, Formation of reactive tissue in the epidural space around the lead, which can cause delayed spinal cord compression and paralysis and requires surgical intervention (Time to onset can range 23 from weeks to many years after implant.). Physicians should also discuss any risks of MRI with patients. Implantation of two systems. Therapeutic magnets. External defibrillators. 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. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. Activities requiring coordination. The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 Damage to shallow implants. Devices with one-hour recharge per day. Electromagnetic interference (EMI). radiofrequency identification (RFID) devices. Patient's visual ability to read the patient controller screen. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. Storage environment. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. 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. Ensure the patients neurostimulation system is in MRI mode. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Stylet handling. Magnetic resonance imaging (MRI). Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Do not use surgical instruments to handle the lead. If the patient requires a CT scan, all stimulation should be turned off before the procedure. 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). 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. Recharge-by date. six to eight weeks after implantation of a neurostimulation system. Diathermy is further prohibited because it may also damage the neurostimulation system components. Infection. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Sheath insertion precaution. Stimulation in unwanted places (such as radicular stimulation of the chest wall), Lead migration, causing changes in stimulation or reduced pain relief, Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant, Persistent pain at the electrode or generator site, Seroma (mass or swelling) at the generator site, Allergic or rejection response to implant materials, Implant migration or skin erosion around the implant. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. 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 . Infections may require that the device be explanted. Neurosurgery Pain Management Orthopaedic Surgery Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Clinician programmers, patient controllers, and chargers are not waterproof. 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). Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. Implantation of two systems. 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. 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). Infection. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. 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 . Changes in blood glucose levels in response to any adverse effect Output power below 80 W is recommended for all activations. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Implantation at vertebral levels above T10. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. High-output ultrasonics and lithotripsy. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. These activities may cause lead movement, resulting in under stimulation or overstimulation for 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. Advance the needle and guidewire slowly. Explosive or flammable gasses. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Return of symptoms and rebound effect. 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). Confirm that no adverse conditions to MR scanning are present. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Security, antitheft, and radiofrequency identification (RFID) devices. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. 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. Caution patients to not make unauthorized changes to physician-established stimulation parameters. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. maximize the distance between the implanted systems; Use in patients with diabetes. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Loss of coordination is a potential side effect of DBS therapy. 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. 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. Security, antitheft, and radiofrequency identification (RFID) devices. separates the implanted IPGs to minimize unintended interaction with other system components. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. 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. 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.