Activities requiring excessive twisting or stretching. 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. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. Keep them dry to avoid damage. Application modification. 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. All components listed must be implanted unless noted as "optional." Sheath retraction. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Proclaim DRG System | Abbott Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Monitor the patients blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. Patients should cautiously approach such devices and should request help to bypass them. Patient activities and environmental precautions. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. 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. 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. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. 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. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. Control of the patient controller. Battery precaution. To find Shipping Material Packaging Waste information, select Healthcare Professionals. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Diathermy is further prohibited because it may also damage the neurostimulation system components. Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Component disposal. 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. 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. Securing the anchor. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Computed tomography (CT). Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. Infection. Clinician programmers, patient controllers, and chargers are not waterproof. Diathermy is further prohibited because it may also damage the neurostimulation system components. This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. Safety and effectiveness of neurostimulation for pediatric use have not been established. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. Infections related to system implantation might require that the device be explanted. Select patients appropriately for deep brain stimulation. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. IPG disposal. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Therapeutic radiation. Generator disposal. This neurostimulation system is contraindicated for patients who are. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Use extreme care when handling system components. 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. High stimulation outputs. Removing each item in slow movements while holding the remaining components in place will assist this process. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. If interference occurs, try holding the phone to the other ear or turning off the phone. 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. Poor surgical risks. The website that you have requested also may not be optimized for your screen size. Operation of machines, equipment, and vehicles. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Confirm the neurostimulation system is functioning. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Lasting Relief through our smallest system yet. If unpleasant sensations occur, the device should be turned off immediately. 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. radiofrequency identification (RFID) devices. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. To prevent injury or damage to the system, do not modify the equipment. Clinician training. Wireless use restrictions. 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. ), 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.). Pediatric use. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. 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. While charging the generator, patients may perceive an increase in temperature at the generator site. 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. 2013;16(5):471-482. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Set the electrosurgery device to the lowest possible energy setting. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. The equipment is not serviceable by the customer. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. The system is intended to be used with leads and associated extensions that are compatible with the system. For this reason, programming at frequencies less than 30 Hz is not recommended. Electrocardiograms. Using the tunneling tool. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Operating the device near gas fumes or vapors could cause them to catch fire. Component manipulation by patients. PDF View Shellock R & D Services, Inc. email: . All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. 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. 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 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 system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Package or component damage. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. Getting an MRI | Medtronic 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. Use caution when sedating the patient. PATIENTS Lead movement. Consumer goods and electronic devices. 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. Keep programmers and controllers dry. 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. Storage environment. Proclaim XR SCS System This damage could result in loss of therapy, requiring additional surgery for system replacement. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. 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. Electromagnetic interference (EMI). Nerve damage may result from traumatic or surgical nerve injury. Component manipulation by patient. Return all explanted generators to Abbott Medical for safe disposal. Implantation of two systems. All components listed must be implanted unless noted as "optional." Generators contain batteries as well as other potentially hazardous materials. Case damage. IPGs contain batteries as well as other potentially hazardous materials. Interference with other devices. Restricted areas. Lead insertion through sheath. Long-term safety and effectiveness. 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.