abbott proclaim spinal cord stimulator mri safety

Activities requiring excessive twisting or stretching. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Charge density can be reduced by lowering the stimulation amplitude or pulse width. 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. Package or component damage. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. The tip of the sheath may whip around and could cause harm to the patient. Consider seeking surgical advice if you cannot easily remove a lead. Patients should cautiously approach such devices and should request help to bypass them. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Control of the patient controller. Free from the hassles of recharging. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. 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. Do not crush, puncture, or burn the generator because explosion or fire may result. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Scuba diving or hyperbaric chambers. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. Device modification. 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. separates the implanted generators to minimize unintended interaction with other system components. For more information, see the clinician programmer manual. 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. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. Ultrasonic scanning equipment. If the programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. Use extreme care when handling system components. If two systems are implanted, ensure that at least 20 cm (8 in.) Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Radiofrequency or microwave ablation. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Failure to provide strain relief may result in lead migration requiring a revision procedure. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Conditional 5. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Exit Surgery mode during intraoperative testing and after the procedure is completed. 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. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. Nerve damage may result from traumatic or surgical nerve injury. 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. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Activities requiring coordination. Advance the needle and guidewire slowly. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. Wireless use restrictions. 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. Security, antitheft, and radiofrequency identification (RFID) devices. Computed tomography (CT). If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Magnetic resonance imaging (MRI). For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Overcommunicating with the IPG. The clinician programmer and patient controller are not waterproof. 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). External defibrillators. For this reason, programming at frequencies less than 30 Hz is not recommended. Component manipulation. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Scuba diving or hyperbaric chambers. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Do not use surgical instruments to handle the lead. While charging the generator, patients may perceive an increase in temperature at the generator site. The equipment is not serviceable by the customer. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. 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. 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). Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Lead damage from tools. 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. commercial electrical equipment (such as arc welders and induction furnaces). 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). Stimulation effectiveness has been established for one year. 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. The website that you have requested also may not be optimized for your screen size. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Application modification. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. 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. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Patients should cautiously approach such devices and should request help to bypass them. Infection. Unwanted changes in stimulation may include a jolting or shocking feeling. All components listed must be implanted unless noted as "optional." Neurostimulation should not be used on patients who are poor surgical candidates. Patient selection. Output power below 80 W is recommended for all activations. Select patients appropriately for deep brain stimulation. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The following precautions apply to this neurostimulation system. Inaccurate ECG results may lead to inappropriate treatment of the patient. Handle the device with care. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Lead movement. 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. If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. Patient's visual ability to read the patient controller screen. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. Therapeutic radiation. Lead movement. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Case damage. Component disposal. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Application modification. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Scuba diving and hyperbaric chambers. Mobile phones. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Conscious sedation. separates the implanted IPGs to minimize unintended interaction with other system components. 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. Infection. Operation of machines, equipment, and vehicles. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established. 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. To prevent unintended stimulation, do not modify the operating system in any way. This equipment is not serviceable by the customer. It is extremely important to select patients appropriately for neurostimulation. Component disposal. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Store components and their packaging where they will not come in contact with liquids of any kind. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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 needed, return the equipment to Abbott Medical for service. If needed, return the equipment to Abbott Medical for service. Do not crush, puncture, or burn these devices because explosion or fire may result. 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. Patients should cautiously approach such devices and should request help to bypass them. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. (2) The method of its application or use. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. If unpleasant sensations occur, turn off stimulation immediately. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Avoid excessive stimulation. 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). The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. The device should be turned off and the doctor contacted if this occurs. Before reinserting the sheath, verify there is no damage to the sheath. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Wireless communications equipment, such as mobile and cordless phones and walkie-talkies, may interfere with the IPG if the equipment gets too close to the IPG. Therapeutic radiation. Interference with other devices. Sheath retraction. To prevent injury or damage to the system, do not modify the equipment. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Return the explanted IPG to Abbott Medical. Set the electrosurgery device to the lowest possible energy setting. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Exposure to body fluids or saline. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. 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. Use appropriate sterile technique when implanting leads and the IPG. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Detailed information on storage environment is provided in the appendix of this manual. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. 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. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Only apply software updates that are published directly by Abbott Medical. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. Return all explanted components to Abbott Medical for safe disposal. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. 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. Care and handling of components. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Cremation. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Use extreme care when handling system components prior to implantation. Multiple leads. INDICATIONS FOR USE PDF View Shellock R & D Services, Inc. email: . After defibrillation, confirm the neurostimulation system is still working. Abandoned leads and replacement leads. radiofrequency identification (RFID) devices. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Surgeon training. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Surgical advice for removal. To prevent unintended stimulation, do not modify the operating system in any way. Damage to shallow implants. Skydiving, skiing, or hiking in the mountains. Patient activities and environmental precautions. Lead inspection. Always perform removal of implanted components with the patient conscious and able to give feedback. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Single-use, sterile device. Keep them dry to avoid damage. Radiofrequency or microwave ablation. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. During the implant procedure, if an electrosurgery device must be used, take the following actions:. 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. 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.

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