We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. 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. 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. This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. FDA Approves Abbott's Spinal Cord Stimulation for People Living with If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Patients should cautiously approach such devices and should request help to bypass them. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Explosive or flammable gasses. Diathermy therapy. 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. Clinician programmers, patient controllers, and chargers are not waterproof. Stylet handling. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Do not crush, puncture, or burn the IPG because explosion or fire may result. Return all explanted components to Abbott Medical for safe disposal. 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. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. 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. For this reason, programming at frequencies less than 30 Hz is not recommended. Avoid excessive stimulation. The tip of the sheath may whip around and could cause harm to the patient. Set the electrosurgery device to the lowest possible energy setting. Lead movement. 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 . Unauthorized changes to stimulation parameters. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. 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. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Implant heating. INDICATIONS FOR USE Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Patients should be advised to not use therapeutic magnets. 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. Programmer and controller devices are not waterproof. A recharge-by date is printed on the packaging. Application modification. Generator disposal. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Set the electrosurgery device to the lowest possible energy setting. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Do not use surgical instruments to handle the lead. Needle insertion. High-output ultrasonics and lithotripsy. Abbott's Proclaim XR Spinal Cord Stimulation System Now - Insider Reducing the Pains of Chronic Pain Treatment | Abbott Newsroom six to eight weeks after implantation of a neurostimulation system. Select patients appropriately for deep brain stimulation. 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. 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. Inserting the anchor. Device modification. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. 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. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Diathermy is further prohibited because it may also damage the neurostimulation system components. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Single-use, sterile device. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. PDF View Shellock R & D Services, Inc. email: . See Full System Components below if the patient has an IPG and extensions implanted. Failure to do so may cause harm to the patient such as damage to the dura. 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. Consumer goods and electronic devices. Have the patient check the device for proper functioning, even if the device was turned off. 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. Implantation of two systems. 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. External defibrillators. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Care and handling of components. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. 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. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Patients should exercise reasonable caution when bathing. Sheath rotation. The clinician programmer and patient controller are not waterproof. Damage to shallow implants. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Do not use the application if the operating system is compromised (that is, jailbroken). Scuba diving and hyperbaric chambers. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. 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 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. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. 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. Patient training. Storage environment. Component handling. For more information, see the clinician programmer manual. MR safety: spinal cord stimulators - Questions and Answers in MRI Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Device modification. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your generator immediately.). Package or component damage. External defibrillators. Explosive and flammable gasses. Component disposal. 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). ), 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.). Lead movement. Loss of coordination is a potential side effect of DBS therapy. Consumer goods and electronic devices. The safety and efficacy of the implantation of greater than four leads have not been evaluated. To prevent injury or damage to the system, do not modify the equipment. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Infection. 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. If the patient requires a CT scan, all stimulation should be turned off before the procedure. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. ** Use extreme care when handling system components. Confirm implant locations and scan requirements for the patients system. Patients should not use this neurostimulation system if they are pregnant or nursing. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Infection. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Read this section to gather important prescription and safety information. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. The safety and effectiveness of neurostimulation for pediatric use have not been established. Ensure the patients neurostimulation system is in MRI mode. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . The operation of these devices could cause them to ignite, causing severe burns, injury, or death. Follow proper infection control procedures. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Do not resterilize or reimplant an explanted system for any reason. Implantation of multiple leads. Infections may require that the device be explanted. Keep dry to avoid damage. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Proclaim XR SCS System Meaningful relief from chronic pain. 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.**. If interference occurs, try holding the phone to the other ear or turning off the phone. Poor surgical risks. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Preventing infection. The effect of mobile phones on deep brain stimulation is unknown. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Return any suspect components to Abbott Medical for evaluation. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Follow proper infection control procedures. 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 needed, return the equipment to Abbott Medical for service. 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. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Storage environment. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Insertion of a sheath without the lead may result in dural puncture. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. 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. 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. 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. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Operating the device near gas fumes or vapors could cause them to catch fire. Patients should cautiously approach such devices and should request help to bypass them. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Security, antitheft, and radiofrequency identification (RFID) devices. Patient activities and environmental precautions. ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. Keep the device dry. Damage to the system may not be immediately detectable. Return all explanted generators to Abbott Medical for safe disposal. Object Info: - MRI Safety High stimulation outputs. To prevent injury or damage to the system, do not modify the equipment. If unpleasant sensations occur, the device should be turned off immediately.
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