The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. 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. Operation of machines, equipment, and vehicles. Transcutaneous electrical nerve stimulation (TENS). Physicians should also discuss any risks of MRI with patients. Programmer and controller devices are not waterproof. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. If lithotripsy must be used, do not focus the energy near the IPG. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Follow proper infection control procedures. Lead insertion through sheath. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Use extreme care to not damage the lead with the sharp point of the tunneling tool. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Electrosurgery. ), 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.). Use care when reinserting a stylet. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. External defibrillators. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. 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. Removing components. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Changes in blood glucose levels in response to any adverse effect Unauthorized changes to stimulation parameters. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Only apply software updates that are published directly by Abbott Medical. Implantation of multiple leads. Confirm that no adverse conditions to MR scanning are present. Place the neurostimulator in Surgery mode before using an electrosurgery device. Set the electrosurgery device to the lowest possible energy setting. 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. 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. Explosive and flammable gasses. Keep the device dry. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 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. Placing 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. Mobile phones. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Free from the hassles of recharging. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Product materials. The equipment is not serviceable by the customer. 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. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Do not crush, puncture, or burn the IPG because explosion or fire may result. If needed, return the equipment to Abbott Medical for service. INDICATIONS FOR USE Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). Avoid programming either device in a unipolar mode (using the devices can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Storage environment. Patient training. Use appropriate sterile technique when implanting leads and the IPG. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Ultrasonic scanning equipment. Sheath retraction. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Postural changes. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. 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. Damage to the system may not be immediately detectable. PDF View Shellock R & D Services, Inc. email: . Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. away from the generator and avoid placing any smart device in a pocket near the generator. 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 the patient requires a CT scan, all stimulation should be turned off before the procedure. This includes oxygen-enriched environments such as hyperbaric chambers. IPGs contain batteries as well as other potentially hazardous materials. Confirm the neurostimulation system is functioning. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. 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. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. 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 equipment is not serviceable by the customer. Securing the anchor. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Operation of machines, equipment, and vehicles. Advise patients about adverse effects. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. If two systems are implanted, ensure that at least 20 cm (8 in.) Operation of machines, equipment, and vehicles. 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. Lead movement. Handle the programmers and controllers with care. If unpleasant sensations occur, the IPG should be turned off immediately. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Do not use the system if the use-before date has expired. Security, antitheft, and radiofrequency identification (RFID) devices. 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. Pain is not resolved. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Stimulation effectiveness has been established for one year. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Clinician programmers, patient controllers, and chargers are not waterproof. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Handle the device with care. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. 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). Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. 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. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite. Radiofrequency or microwave ablation. Devices with one-hour recharge per day. Return of symptoms and rebound effect. Neuromodulation. 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. Overcommunicating with the IPG. Preventing infection. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Generators contain batteries as well as other potentially hazardous materials. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. 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. Poor surgical risks. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. 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. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Diathermy therapy. Case damage. This neurostimulation system is contraindicated for patients who are. Scuba diving or hyperbaric chambers. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Bathing. Lead movement. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Keep them dry to avoid damage. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. Electromagnetic interference (EMI). Unwanted changes in stimulation may include a jolting or shocking feeling. Ensure the patients neurostimulation system is in MRI mode. While charging the generator, patients may perceive an increase in temperature at the generator site. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. 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). For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. 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). Keep dry to avoid damage. Remove leads slowly. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Do not use surgical instruments to handle the lead. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Sheath insertion precaution. Cremation. 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Output power below 80 W is recommended for all activations. Security, antitheft, and radiofrequency identification (RFID) devices. 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. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Wireless use restrictions. Security, antitheft, and radiofrequency identification (RFID) devices. Patients should cautiously approach such devices and should request help to bypass them. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). 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. Follow proper infection control procedures. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Infections may require that the device be explanted. Operating the device near gas fumes or vapors could cause them to catch fire. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) External defibrillators. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Component disposal. Patients should be advised to not use therapeutic magnets. Thorough psychiatric screening should be performed. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Removing each item in slow movements while holding the remaining components in place will assist this process. 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. 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 cautiously approach such devices and should request help to bypass them. Return all explanted generators to Abbott Medical for safe disposal. Patients should avoid charging their generator over an incision that has not completely healed. Keep them dry to avoid damage. 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. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. ); 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. Failure to do so can damage or cut the lead or sheath. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Failure to do so may result in difficulty delivering the lead. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Lead movement. Poor surgical risks. Component manipulation. commercial electrical equipment (such as arc welders and induction furnaces). All components listed must be implanted unless noted as "optional." 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. Neurosurgery Pain Management Orthopaedic Surgery 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.
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