Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Confirm that no adverse conditions to MR scanning are present. If lithotripsy must be used, do not focus the energy near the IPG. Safety and effectiveness of neurostimulation for pediatric use have not been established. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. 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 lithotripsy must be used, do not focus the energy near the generator. Equipment is not serviceable by the customer. Device profile of the Proclaim XR neurostimulation system for the Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Set the electrosurgery device to the lowest possible energy setting. Magnetic resonance imaging (MRI). Lead inspection. 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. Proclaim XR SCS System If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. 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. Lead movement. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Do not crush, puncture, or burn these devices because explosion or fire may result. PDF View Shellock R & D Services, Inc. email: . 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. Device modification. 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 a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Output power below 80 W is recommended for all activations. 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). IPG disposal. 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. 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. 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. The clinician programmer and patient controller are not waterproof. MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott Risk of depression, suicidal ideations, and suicide. Generator disposal. Deep brain stimulation complications include, but are not limited to, the following: Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture, Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture, Initial jolt or tingling during stimulation; jolting or shocking sensations, Lead fracture, migration, or dislodgement, Extension malfunction, fracture, or disconnect, Deep brain stimulation system failure or battery failure within the device, Deep brain stimulation system malfunction or dislodgement, Allergic or rejection response to implanted materials, Persistent pain, tightness, or redness at the incision sites or general pain, General erosion or local skin erosion over the IPG, Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck), Impaired wound healing (e.g., incision site drainage) or abscess formation, Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component, Stimulation-related complications or other complications, Worsening of motor impairment and Parkinsons disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia, Paresis, asthenia, hemiplegia, or hemiparesis, Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance, Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia, Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium, Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope), Eye disorder including eye apraxia or blepharospasm, (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. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Electrical medical treatment. MRI Support | Abbott Neuromodulation Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. 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. Proclaim DRG System | Abbott Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Abbott - Spinal Cord Stimulation Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. INDICATIONS FOR USE Suicidal ideation, suicide attempts, and suicide are events that have also been reported. 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. Explosive and flammable gasses. 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). Before reinserting the sheath, verify there is no damage to the sheath. Wireless use restrictions. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. 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). Detailed information on storage environment is provided in the appendix of this manual. Securing the anchor. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. 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. However, some patients may experience a decrease or increase in the perceived level of stimulation. If needed, return the equipment to Abbott Medical for service. High stimulation outputs. This damage could result in loss of therapy, requiring additional surgery for system replacement. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Care and handling of components. To prevent injury or damage to the system, do not modify the equipment. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. 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. Activities requiring coordination. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. High-output ultrasonics and lithotripsy. Application modification. External defibrillators. radiofrequency identification (RFID) devices. Diathermy therapy. Conscious sedation during removal. If two systems are implanted, ensure that at least 20 cm (8 in.) The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Product materials. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Do not use the application if the operating system is compromised (that is, jailbroken). If unpleasant sensations occur, the device should be turned off immediately. 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. Computed tomography (CT). After defibrillation, confirm the neurostimulation system is still working. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Damage to the system may not be immediately detectable. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Lead movement. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Do not crush, puncture, or burn the IPG because explosion or fire may result. Read this section to gather important prescription and safety information. The Proclaim XR SCS system can provide relief to . IPGs contain batteries as well as other potentially hazardous materials. 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. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Return the explanted IPG to Abbott Medical. Do not use the system if the use-before date has expired. Interference with other devices. Return all explanted components to Abbott Medical for safe disposal. 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. 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). Component disposal. ** Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Make the Bold Choice Operation of machines, equipment, and vehicles. Follow proper infection control procedures. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Our Invisible Trial System TM is a discreet, app . Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Implanted cardiac systems. 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. 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 neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Neuromodulation. Place the neurostimulator in Surgery mode before using an electrosurgery device. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. Changes in blood glucose levels in response to any adverse effect If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. 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. Scuba diving or hyperbaric chambers. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Patients should cautiously approach such devices and should request help to bypass them. Transcutaneous electrical nerve stimulation (TENS). Damage to the system may not be immediately detectable. 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. If needed, return the equipment to Abbott Medical for service. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Patient training. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Patient activities and environmental precautions. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. FDA's expanded . If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Consider seeking surgical advice if you cannot easily remove a lead. Device modification. 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 operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. External defibrillators. 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. For more information, see the clinician programmer manual. 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. Thorough psychiatric screening should be performed. Therapeutic radiation. If interference occurs, try holding the phone to the other ear or turning off the phone. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. 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. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Electrosurgery. Always perform removal with the patient conscious and able to give feedback. away from the generator and avoid placing any smart device in a pocket near the generator. Return any suspect components to Abbott Medical for evaluation. Confirm implant locations and scan requirements for the patients system. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Proclaim XR SCS System Meaningful relief from chronic pain. Battery care. 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. To prevent injury or damage to the system, do not modify the equipment. 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. Set the electrosurgery device to the lowest possible energy setting. To prevent unintended stimulation, do not modify the generator software in any way. 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. Lead damage from tools. 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. Wireless use restrictions. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Therapeutic magnets. 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. All components listed must be implanted unless noted as "optional." Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. 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. Keep them dry to avoid damage. 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. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. 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. 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's Proclaim XR Spinal Cord Stimulation System Now - Insider Devices with one-hour recharge per day. 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. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions.
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