Physicians should also discuss any risks of MRI with patients. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. ), 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.). 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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. Lead movement. If needed, return the equipment to Abbott Medical for service. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. 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 . Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. A recharge-by date is printed on the packaging. Conscious sedation. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. 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. 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. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Magnetic resonance imaging (MRI). Proclaim XR SCS System Meaningful relief from chronic pain. Remove leads slowly. This includes oxygen-enriched environments such as hyperbaric chambers. 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. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Removing components. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. Handle the device with care. Use extreme care when handling system components. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. High stimulation outputs. Preventing infection. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. 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. System testing. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. radiofrequency identification (RFID) devices. 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. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Implantation at vertebral levels above T10. Stimulation Modes. Failure to do so may cause harm to the patient such as damage to the dura. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Always perform removal with the patient conscious and able to give feedback. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Unwanted changes in stimulation may include a jolting or shocking feeling. Nerve damage may result from traumatic or surgical nerve injury. Care and handling of components. The system is intended to be used with leads and associated extensions that are compatible with the system. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. Do not resterilize or reimplant an explanted system for any reason. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. 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. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Application modification. Lead damage from tools. Patient selection. Activities requiring coordination. High-output ultrasonics and lithotripsy. Multiple leads. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. Clinician training. 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 prevent injury or damage to the system, do not modify the equipment. Package or component damage. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). 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. Electromagnetic interference (EMI). 2013;16(5):471-482. Radiofrequency or microwave ablation. Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Electromagnetic interference (EMI). This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Patients should cautiously approach such devices and should request help to bypass them. Number of leads implanted. Bending the sheath. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Read this section to gather important prescription and safety information. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. 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. 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. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. 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 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) 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. During the implant procedure, if an electrosurgery device must be used, take the following actions:. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Follow proper infection control procedures. Removing each item in slow movements while holding the remaining components in place will assist this process. Skin erosion. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might 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. 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. 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. Do not crush, puncture, or burn the generator because explosion or fire may result. Case damage. **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. Application modification. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Diathermy is further prohibited because it may also damage the neurostimulation system components. Learn more about the scan details for our MR Conditional products below. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. separates the implanted IPGs to minimize unintended interaction with other system components. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Household appliances. 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. Wireless use restrictions. Patients should cautiously approach such devices and should request help to bypass them. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Infections may require that the device be explanted. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Scuba diving and hyperbaric chambers. Return all explanted IPGs to Abbott Medical for safe disposal. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. After defibrillation, confirm the neurostimulation system is still working. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Sheath retraction. The tip of the sheath may whip around and could cause harm to the patient. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Other active implantable devices. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. 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. If lithotripsy must be used, do not focus the energy near the IPG. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. 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. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. commercial electrical equipment (such as arc welders and induction furnaces). When multiple leads are implanted, route the lead extensions so the area between them is minimized. Patients should avoid charging their generator over an incision that has not completely healed. 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). Use extreme care when handling system components prior to implantation. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Activities requiring excessive twisting or stretching. 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. Scuba diving or hyperbaric chambers. 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. Pediatric use. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly.
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