Patients should avoid charging their generator over an incision that has not completely healed. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Care and handling of components. Avoid excessive stimulation. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Implant heating. If multiple leads are implanted, leads and extensions should be routed in close proximity. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Placement of lead connection in neck. Failure to do so may cause harm to the patient such as damage to the dura. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Security, antitheft, and radiofrequency identification (RFID) devices. Clinician programmers, patient controllers, and chargers are not waterproof. Advance the needle and guidewire slowly. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation 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. Case damage. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Implantation at vertebral levels above T10. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Mobile phones. If interference occurs, try holding the phone to the other ear or turning off the phone. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Risk of depression, suicidal ideations, and suicide. Operating the device near gas fumes or vapors could cause them to catch fire. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. The force of the instruments may damage the lead or stylet. Device modification. Follow proper infection control procedures. Stabilizing the lead during insertion. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. Failure to do so can damage or cut the lead or sheath. 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. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. 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.**. Keep them dry to avoid damage. Stimulation effectiveness has been established for one year. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. 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. This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. Device modification. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Set the electrosurgery device to the lowest possible energy setting. High stimulation outputs. Battery precaution. Pediatric use. Excessive lead migration may require reoperation to replace the leads. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. High-output ultrasonics and lithotripsy. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Radiofrequency or microwave ablation. If lithotripsy must be used, do not focus the energy near the IPG. Storage environment. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Physicians should also discuss any risks of MRI with patients. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. 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 Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Explosive or flammable gasses. Physicians should also discuss any risks of MRI with patients. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Poor surgical risks. Activities requiring coordination. 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. ), 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.). 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. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Storage environment. 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. 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. Ultrasonic scanning equipment. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. System testing. 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. 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. Always be aware of the needle tip position. Programmer and controller devices are not waterproof. IPG placement. Exposure to body fluids or saline. Confirm the neurostimulation system is functioning. See Full System Components below if the patient has an IPG and extensions implanted. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. 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. If unpleasant sensations occur, the device should be turned off immediately. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Up to two leads, lead protection boots, and burr hole covers may be implanted. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Failure to do so may result in damage to the sheath. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Surgical advice for removal. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. In rare cases, this can create a medical emergency. If unpleasant sensations occur, turn off stimulation immediately. 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. Use care when reinserting a stylet. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Do not use the application if the operating system is compromised (i.e., jailbroken). Our Invisible Trial System TM is a discreet, app . 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. 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. Return the explanted IPG to Abbott Medical. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Interference with other devices. ); 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. Cremation. While charging the generator, patients may perceive an increase in temperature at the generator site. For this reason, programming at frequencies less than 30 Hz is not recommended. 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 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. To prevent injury or damage to the system, do not modify the equipment. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. 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. Do not suture directly onto the lead to avoid damaging the lead. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Failure to provide strain relief may result in lead migration requiring a revision procedure. away from the generator and avoid placing any smart device in a pocket near the generator. Clinician training. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. Remove leads slowly. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Using the tunneling tool. Mobile phones. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Patients should exercise reasonable caution when bathing. 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 safety and effectiveness of neurostimulation for pediatric use have not been established. 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.). As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. 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. 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). Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. 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. (2) The method of its application or use. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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. Avoid placing equipment components directly over other electronic devices. Stimulation Modes. Needle positioning. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Only apply software updates that are published directly by Abbott Medical. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. 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. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Lead movement. Scuba diving or hyperbaric chambers. 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. 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). The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Always perform removal with the patient conscious and able to give feedback. IPGs contain batteries as well as other potentially hazardous materials. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. 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. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. 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. All components listed must be implanted unless noted as "optional." Recharge-by date. Clinician training. If the patient requires a CT scan, all stimulation should be turned off before the procedure. After defibrillation, confirm the neurostimulation system is still working. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Component disposal. Follow proper infection control procedures. separates the implanted generators to minimize unintended interaction with other system components. 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,. Device components. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the 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. 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. Store components and their packaging where they will not come in contact with liquids of any kind. 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. Make the Bold Choice (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). The safety and efficacy of the implantation of greater than four leads have not been evaluated. Bending the sheath. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). 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. Security, antitheft, and radiofrequency identification (RFID) devices. Return any suspect components to Abbott Medical for evaluation. Do not use the application if the operating system is compromised (that is, jailbroken). Control of the patient controller. The following warnings apply to this neurostimulation system. 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. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. The system is intended to be used with leads and associated extensions that are compatible with the system. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Damage to the system may not be immediately detectable. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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). 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). 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. 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. 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. Return all explanted components to Abbott Medical for safe disposal. 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. *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. Keep them dry to avoid damage. maximize the distance between the implanted systems; Use in patients with diabetes. Use caution when sedating the patient. Infection. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Do not crush, puncture, or burn the IPG because explosion or fire may result. If two systems are implanted, ensure that at least 20 cm (8 in.) Generators contain batteries as well as other potentially hazardous materials. 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Placing the IPG. 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 and induce voltage through the lead that could jolt or shock the patient. 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 result in difficulty delivering the lead. Infections may require that the device be explanted. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Unwanted changes in stimulation may include a jolting or shocking feeling. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. Component manipulation by patient. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Lead damage from tools.