Sheath insertion warning. Pregnancy and nursing. 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. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. Lead inspection. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. 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. 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. Patients who are unable to properly operate the system. Package or component damage. Inserting the anchor. Exposure to body fluids or saline. Single-use, sterile device. 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. ), 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.). Scanning under different conditions may cause device malfunction, severe patient injury, or death. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Read this section to gather important prescription and safety information. To find Shipping Material Packaging Waste information, select Healthcare Professionals. 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. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). For this reason, programming at frequencies less than 30 Hz is not recommended. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Application modification. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Return all explanted generators to Abbott Medical for safe disposal. 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. 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. 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. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. 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. 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. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. radiofrequency identification (RFID) devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. away from the generator and avoid placing any smart device in a pocket near the generator. 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). Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Do not crush, puncture, or burn the IPG because explosion or fire may result. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Neuromodulation. Sheath rotation. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. 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). Patients should cautiously approach such devices and should request help to bypass them. Diathermy is further prohibited because it may also damage the neurostimulation system components. Thorough psychiatric screening should be performed. 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. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). Wireless use restrictions. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. 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. Do not use excessive pressure when injecting through the sheath. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. 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. Recharge-by date. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Handle the programmers and controllers with care. However, some patients may experience a decrease or increase in the perceived level of stimulation. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. This equipment is not serviceable by the customer. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Return all explanted components to Abbott Medical for safe disposal. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. 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 system may not be immediately detectable. Place the neurostimulator in Surgery mode before using an electrosurgery device. 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.**. This includes oxygen-enriched environments such as hyperbaric chambers. 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. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Patients should cautiously approach such devices and should request help to bypass them. To prevent injury or damage to the system, do not modify the equipment. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Stabilizing the lead during insertion. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. If lithotripsy must be used, do not focus the energy near the IPG. High-output ultrasonics and lithotripsy. Read this section to gather important prescription and safety information. Remove leads slowly. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. 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. 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. Only apply software updates that are published directly by Abbott Medical. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. To prevent injury or damage to the system, do not modify the equipment. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. 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. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Keep the device dry. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Loss of coordination is a potential side effect of DBS therapy. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Lead movement. 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. External defibrillators. 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. 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 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. Electromagnetic interference (EMI). 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. 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. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Failure to do so can damage or cut the lead or sheath. Keep dry to avoid damage. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. If unpleasant sensations occur, the IPG should be turned off immediately. 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. The U.S. Food and Drug Administration (FDA) has approved Abbott 's request to expand the magnetic resonance imaging (MRI) compatibility with its Proclaim XR spinal cord stimulation system with . Failure to do so may cause harm to the patient such as damage to the dura. The placement of the leads involves some risk, as with any surgical procedure. Patient training. Removing components. See Full System Components below if the patient has an IPG and extensions implanted. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Confirm the neurostimulation system is functioning correctly after the procedure. Implantation of two systems. Physicians should also discuss any risks of MRI with patients. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. 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. Restricted areas. 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. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Store components and their packaging where they will not come in contact with liquids of any kind. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Neurosurgery Pain Management Orthopaedic Surgery Application modification. Scuba diving and hyperbaric chambers. Advise patients about adverse effects. Storage environment. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Remove the stylet from the lead only when satisfied with lead placement. 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. Coagulopathies. Detailed information on storage environment is provided in the appendix of this manual. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. 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. Consumer goods and electronic devices. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. To prevent unintended stimulation, do not modify the operating system in any way. communication equipment (such as microwave transmitters and high-power amateur transmitters). Other active implantable devices. 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. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Pregnancy and nursing. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Infections may require that the device be explanted. Security, antitheft, and radiofrequency identification (RFID) devices. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). Preventing infection. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. Inaccurate ECG results may lead to inappropriate treatment of the patient. Cremation. All components listed must be implanted unless noted as "optional." If they must go through a gate or doorway containing this type of device, patients should turn off their generator and proceed with caution, being sure to move through the device quickly. 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. 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. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Clinician programmers, patient controllers, and chargers are not waterproof. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Explosive or flammable gasses. Stylet handling. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Component disposal. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Security, antitheft, and radiofrequency identification (RFID) devices. Electromagnetic interference (EMI). Securing the anchor. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. 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. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Failure to do so may result in damage to the sheath. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. 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. 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. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). 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. Product materials. If the patient requires a CT scan, all stimulation should be turned off before the procedure. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. 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.). 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. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. IPGs contain batteries as well as other potentially hazardous materials. Patients should cautiously approach such devices and should request help to bypass them. 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. Operation of machines, equipment, 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. 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. A recharge-by date is printed on the packaging. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures.
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