abbott proclaim spinal cord stimulator mri safety abbott proclaim spinal cord stimulator mri safety

Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Output power below 80 W is recommended for all activations. 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. 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 clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Securing the IPG. Return all explanted components to Abbott Medical for safe disposal. Place the neurostimulator in Surgery mode before using an electrosurgery device. 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. Electromagnetic interference (EMI). 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. Back pain. 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. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. 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. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Equipment is not serviceable by the customer. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. If lithotripsy must be used, do not focus the energy near the IPG. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. 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. Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Implantation of two systems. 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. Always perform removal with the patient conscious and able to give feedback. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. 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. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Computed tomography (CT). Failure to do so may cause harm to the patient such as damage to the dura. Failure to do so can damage or cut the lead or sheath. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Pediatric use. If unpleasant sensations occur, turn off stimulation immediately. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Select patients appropriately for deep brain stimulation. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. The safety and effectiveness of neurostimulation for pediatric use have not been established. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. 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. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. 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. Therapeutic radiation. If the stylet is removed from the lead, it may be difficult to reinsert it. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Conscious sedation during removal. 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. separates the implanted IPGs to minimize unintended interaction with other system components. Wireless use restrictions. Transcutaneous electrical nerve stimulation (TENS). Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Device components. Loss of coordination is a potential side effect of DBS therapy. communication equipment (such as microwave transmitters and high-power amateur transmitters). This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Emergency procedures. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used. The website that you have requested also may not be optimized for your screen size. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. Confirm the neurostimulation system is functioning correctly after the procedure. Component manipulation. ), 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.). Nerve damage may result from traumatic or surgical nerve injury. 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. In rare cases, this can create a medical emergency. Patients should cautiously approach such devices and should request help to bypass them. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. If lithotripsy must be used, do not focus the energy near the IPG. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. All components listed must be implanted unless noted as "optional." 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. Risk of depression, suicidal ideations, and suicide. Bending the sheath. Failure to do so may result in difficulty delivering the lead. Return them to Abbott Medical for proper disposal. 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. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. 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). Using the tunneling tool. The clinician programmer and patient controller are not waterproof. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Conversely, the other active implanted device may interfere with the operation of 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Battery precaution. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. The effect of mobile phones on deep brain stimulation is unknown. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Insertion of a sheath without the lead may result in dural puncture. 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. Physicians should also discuss any risks of MRI with patients. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. Lead damage from tools. Electrosurgery. High stimulation outputs and charge density limits. Inserting the anchor. 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. Read this section to gather important prescription and safety information. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. To prevent unintended stimulation, do not modify the generator software in any way. Mobile phones. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . 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. 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. Product materials. January 4, 2022 By Sean Whooley. 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. Failure to do so may result in damage to the sheath. Detailed information on storage environment is provided in the appendix of this manual. Restricted areas. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. 737202011056 v5.0 | Item approved for U.S. use only. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. Security, antitheft, and radiofrequency identification (RFID) devices. Application modification. Case damage. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. The implanted components of this neurostimulation system are intended for a single use only. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Confirm implant locations and scan requirements for the patients system. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Stimulation Modes. 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. 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). 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. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. Remove leads slowly. 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. Ultrasonic scanning equipment. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. An expiration date (or use-before date) is printed on the packaging. If needed, return the equipment to Abbott Medical for service. Handle the device with care. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. maximize the distance between the implanted systems; Use in patients with diabetes. This damage could result in loss of therapy, requiring additional surgery for system replacement. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Patients should be advised to not use therapeutic magnets. Long-term safety and effectiveness. 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. Abandoned leads and replacement leads. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Damage to the system may not be immediately detectable. 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. 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). (2) The method of its application or use. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) 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. Have the patient check the device for proper functioning, even if the device was turned off. Return the explanted IPG to Abbott Medical. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). Lead inspection. 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, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves Component disposal. 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. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Surgeon training. Package or component damage. Use care when reinserting a stylet. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). IPG disposal. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Pregnancy and nursing. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Always be aware of the needle tip position. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. 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. 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. If two systems are implanted, ensure that at least 20 cm (8 in.) Patients should cautiously approach such devices and should request help to bypass them. Neurostimulation systems have materials that come in contact or may come in contact with tissue. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode.