Implantation of multiple leads. Patients should cautiously approach such devices and should request help to bypass them. Proclaim XR SCS System Meaningful relief from chronic pain. To prevent unintended stimulation, do not modify the generator software in any way. The equipment is not serviceable by the customer. High stimulation outputs and charge density limits. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. PDF View Shellock R & D Services, Inc. email: . During the implant procedure, if an electrosurgery device must be used, take the following actions:. The safety and efficacy of the implantation of greater than four leads have not been evaluated. The clinician programmer and patient controller are not waterproof. Place the neurostimulator in Surgery mode before using an electrosurgery device. Operation of machines, equipment, and vehicles. High-output ultrasonics and lithotripsy. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. If two systems are implanted, ensure that at least 20 cm (8 in.) Advance the needle and guidewire slowly. Pregnancy and nursing. Securing the IPG. Package or component damage. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. away from the generator and avoid placing any smart device in a pocket near the generator. Security, antitheft, and radiofrequency identification (RFID) devices. Infections may require that the device be explanted. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). When multiple leads are implanted, route the lead extensions so the area between them is minimized. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Mobile phones. Securing the lead with the lead stabilizer will mitigate this risk. Devices with one-hour recharge per day. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. 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. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Patients should cautiously approach such devices and should request help to bypass them. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. If interference occurs, try holding the phone to the other ear or turning off the phone. Care and handling of components. If the stylet is removed from the lead, it may be difficult to reinsert it. Exit Surgery mode during intraoperative testing and after the procedure is completed. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. 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. Abandoned leads and replacement leads. commercial electrical equipment (such as arc welders and induction furnaces). Safety and effectiveness of neurostimulation for pediatric use have not been established. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Lead damage from tools. Needle insertion. If needed, return the equipment to Abbott Medical for service. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. If lithotripsy must be used, do not focus the energy near the generator. Restricted areas. Scuba diving or hyperbaric chambers. 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). For this reason, programming at frequencies less than 30 Hz is not recommended. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. If radiation therapy is required, the area over the implanted generator should be shielded with lead. With the Proclaim XR SCS system, you can have hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings* without ever needing to charge the system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. 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). Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. January 4, 2022 By Sean Whooley. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Radiofrequency or microwave ablation. 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. Stabilizing the lead during insertion. 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. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Failure to provide strain relief may result in lead migration requiring a revision procedure. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. 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. Damage to the system may not be immediately detectable. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Therapeutic radiation. Exposure to body fluids or saline. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. 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. Lead movement. 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. Only apply software updates that are published directly by Abbott Medical. separates the implanted generators to minimize unintended interaction with other system components. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. Physicians should also discuss any risks of MRI with patients. Scuba diving or hyperbaric chambers. 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. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. Activities requiring excessive twisting or stretching. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Other active implantable devices. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Household appliances. Therapeutic magnets. Security, antitheft, and radiofrequency identification (RFID) devices. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Computed tomography (CT). Return all explanted components to Abbott Medical for safe disposal. Application modification. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Return all explanted generators to Abbott Medical for safe disposal. Single-use, sterile device. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. 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. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Explosive and flammable gasses. 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. Damage to the system may not be immediately detectable. Follow proper infection control procedures. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. 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. Failure to do so can damage or cut the lead or sheath. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Sheath insertion precaution. 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.
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