abbott proclaim spinal cord stimulator mri safety

and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. 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. Therapeutic radiation. Wireless use restrictions. commercial electrical equipment (such as arc welders and induction furnaces). For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Patients should not use this neurostimulation system if they are pregnant or nursing. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). To prevent injury or damage to the system, do not modify the equipment. 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. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Recharge-by date. Exposure to body fluids or saline. 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. 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. Securing the IPG. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Electrical medical treatment. 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. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. 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. If unpleasant sensations occur, the IPG should be turned off immediately. separates the implanted IPGs to minimize unintended interaction with other system components. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. Damage to shallow implants. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. 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). Security, antitheft, and radiofrequency identification (RFID) devices. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. 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. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Pediatric use. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Patients should cautiously approach such devices and should request help to bypass them. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Bathing. Patients who are unable to properly operate the system. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Interference with wireless equipment. Remove the stylet from the lead only when satisfied with lead placement. Keep them dry to avoid damage. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Implantation of multiple leads. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) 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. 737202011056 v5.0 | Item approved for U.S. use only. Surgeon training. Do not use the system if the use-before date has expired. Patient selection. Neuromodulation. 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. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Cremation. Read this section to gather important prescription and safety information. Device modification. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Exit Surgery mode during intraoperative testing and after the procedure is completed. Infection. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. This includes oxygen-enriched environments such as hyperbaric chambers. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Stimulation effectiveness has been established for one year. 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. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Sheath insertion warning. 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. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. Securing the lead with the lead stabilizer will mitigate this risk. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Use extreme care when handling system components prior to implantation. Magnetic resonance imaging (MRI). If needed, return the equipment to Abbott Medical for service. 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. Case damage. Battery precaution. Number of leads implanted. 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. Our Invisible Trial System TM is a discreet, app . If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 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. The equipment is not serviceable by the customer. Do not crush, puncture, or burn the IPG because explosion or fire may result. Use appropriate sterile technique when implanting leads and the IPG. Risk of depression, suicidal ideations, and suicide. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Confirm implant locations and scan requirements for the patients system. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. 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 following precautions apply to this neurostimulation system. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Physicians should also discuss any risks of MRI with patients. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Case damage. Postural changes. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. Package or component damage. Surgical advice for removal. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. 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. Operation of machines, equipment, and vehicles. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinsons disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return. ** For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. Set the electrosurgery device to the lowest possible energy setting. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. Patients should cautiously approach such devices and should request help to bypass them. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Removing components. Do not suture directly onto the lead to avoid damaging the lead. Generators contain batteries as well as other potentially hazardous materials. 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). 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Use extreme care to not damage the lead with the sharp point of the tunneling tool. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Programmer use. During the implant procedure, if an electrosurgery device must be used, take the following actions:. 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,. Infections related to system implantation might require that the device be explanted. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. 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. Failure to do so may result in difficulty delivering the lead. 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. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system. If interference occurs, try holding the phone to the other ear or turning off the phone. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. 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. 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. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Patients should cautiously approach such devices and should request help to bypass them. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. 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. 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. Product materials. The device should be turned off and the doctor contacted if this occurs. 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. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. 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. 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. Placement of lead connection in neck. 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. Always perform removal with the patient conscious and able to give feedback. Storage environment. 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. 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. The Proclaim XR SCS system can provide relief to . Have the patient check the device for proper functioning, even if the device was turned off. Store components and their packaging where they will not come in contact with liquids of any kind. Diathermy is further prohibited because it may also damage the neurostimulation system components. Pediatric use. If unpleasant sensations occur, the device should be turned off immediately. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Caution patients to not make unauthorized changes to physician-established stimulation parameters. 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.

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