abbott proclaim spinal cord stimulator mri safety

Do not suture directly onto the lead to avoid damaging the lead. Sheath retraction. 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. If two systems are implanted, ensure that at least 20 cm (8 in.) Up to two leads, lead protection boots, and burr hole covers may be implanted. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Patient training. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. All components listed must be implanted unless noted as "optional." Confirm the neurostimulation system is functioning correctly after the procedure. If lithotripsy must be used, do not focus the energy near the generator. 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. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Damage to the system may not be immediately detectable. The placement of the leads involves some risk, as with any surgical procedure. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Surgical advice for removal. Additional Disadvantages. Package or component damage. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. INDICATIONS FOR USE 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. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Diathermy therapy. 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. 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. Needle insertion. 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.**. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. 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. 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. Insertion of a sheath without the lead may result in dural puncture. Patients should exercise reasonable caution when bathing. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Damage to shallow implants. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. 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. 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 safety and efficacy of the implantation of greater than four leads have not been evaluated. Neurostimulation systems have materials that come in contact or may come in contact with tissue. ); 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. 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. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. 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. 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. See Full System Components below if the patient has an IPG and extensions implanted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Failure to do so may cause harm to the patient such as damage to the dura. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Ultrasonic scanning equipment. Poor surgical risks. Implantation of two systems. Application modification. Generator disposal. 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. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. Our Invisible Trial System TM is a discreet, app . Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance. Return the explanted IPG to Abbott Medical. Needle positioning. 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 placement. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Operation of machines, equipment, and vehicles. Proclaim XR SCS System Meaningful relief from chronic pain. Lead insertion through sheath. The following precautions apply to this neurostimulation system. Return all explanted components to Abbott Medical for safe disposal. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. 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. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. 21 CR 801.109(b) The label of the device, other than surgical instruments, bears: (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. The Eterna SCS 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. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Conscious sedation during removal. Do not resterilize or reimplant an explanted system for any reason. 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. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. The tip of the sheath may whip around and could cause harm to the patient. Electromagnetic interference (EMI). Back pain. Do not use the application if the operating system is compromised (i.e., jailbroken). When multiple leads are implanted, route the lead extensions so the area between them is minimized. Electrical medical treatment. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Remove leads slowly. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. 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. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Advise patients about adverse effects. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Keep the device dry. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). To prevent injury or damage to the system, do not modify the equipment. 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. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. 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. Lead movement. Read this section to gather important prescription and safety information. Other active implantable devices. away from the generator and avoid placing any smart device in a pocket near the generator. 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). Excessive lead migration may require reoperation to replace the leads. 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). In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Operation of machines, equipment, and vehicles. Explosive and flammable gasses. Return of symptoms and rebound effect. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Before reinserting the sheath, verify there is no damage to the sheath. Stylet handling. High-output ultrasonics and lithotripsy. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. radiofrequency identification (RFID) devices. Wireless use restrictions. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Make the Bold Choice 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. Case 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. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Removing 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Safety Info ID# Safety Topic / Subject Article Text 294: Spinal Cord Stimulation Systems: St. Jude Medical: Genesis, GenesisXP, GenesisRC, Eon, Eon C, Eon Mini, and Renew The Genesis, GenesisXP, GenesisRC, Eon, EonC, Eon Mini, and Renew neuromodulation devices (St. Jude Medical) used for spinal cord stimul. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). 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. Lead handling. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Do not use the application if the operating system is compromised (that is, jailbroken). 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. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Electrocardiograms. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Exit Surgery mode during intraoperative testing and after the procedure is completed. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). The system is intended to be used with leads and associated extensions that are compatible with the system. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Component manipulation by patients. Keep them dry to avoid damage. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Set the electrosurgery device to the lowest possible energy setting. The effect of mobile phones on deep brain stimulation is unknown. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. Implantation of multiple leads. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Unwanted changes in stimulation may include a jolting or shocking feeling. Wireless use restrictions. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. 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. 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. 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.). Use care when reinserting a stylet. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Security, antitheft, and radiofrequency identification (RFID) devices. Security, antitheft, and radiofrequency identification (RFID) devices. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Mobile phones. Bathing. To prevent injury or damage to the system, do not modify the equipment. Lead damage from tools. For more information, see the clinician programmer manual. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Stabilizing the lead during insertion. 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. Use extreme care to not damage the lead with the sharp point of the tunneling tool. The Proclaim TM SCS System is also the first upgradeable and recharge-free spinal cord stimulation system capable of delivering both tonic stimulation and Abbott's proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain. Confirm implant locations and scan requirements for the patients system. 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. Neuromodulation. 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. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Do not use surgical instruments to handle the lead. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Care and handling of components. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. Stimulation effectiveness. IPGs contain batteries as well as other potentially hazardous materials. Sheath insertion warning. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Patient activities and environmental precautions. Patient's visual ability to read the patient controller screen. If the stylet is removed from the lead, it may be difficult to reinsert it. Single-use, sterile device. The equipment is not serviceable by the customer. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Long-term safety and effectiveness. Security, antitheft, and radiofrequency identification (RFID) devices. 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.

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