** Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Scuba diving or hyperbaric chambers. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Device components. Patient's visual ability to read the patient controller screen. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. 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. Needle insertion. Programmer use. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Preventing infection. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. 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. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Insertion of a sheath without the lead may result in dural puncture. 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. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Operating the device near gas fumes or vapors could cause them to catch fire. Postural changes. Before reinserting the sheath, verify there is no damage to the sheath. INDICATIONS FOR USE Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Infections related to system implantation might require that the device be explanted. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. To prevent unintended stimulation, do not modify the operating system in any way. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. 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. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. *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. 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 at medical.abbott/manuals). Do not use the system if the use-before date has expired. 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.). Number of leads implanted. The safety and effectiveness of neurostimulation for pediatric use have not been established. Infection. Component handling. 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). Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Battery precaution. Exit Surgery mode during intraoperative testing and after the procedure is completed. 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. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. Failure to do so can damage or cut the lead or sheath. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Patients should exercise reasonable caution when bathing. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Magnetic resonance imaging (MRI). Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. 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. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Providing strain relief. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. The equipment is not serviceable by the customer. Placing the IPG. Do not use excessive pressure when injecting through the sheath. Free from the hassles of recharging. Implantation of multiple leads. Keep the device dry. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. The tip of the sheath may whip around and could cause harm to the patient. Stimulation Modes. Make the Bold Choice Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. All components listed must be implanted unless noted as "optional." To find Shipping Material Packaging Waste information, select Healthcare Professionals. Caution patients to not make unauthorized changes to physician-established stimulation parameters. If unpleasant sensations occur, the device should be turned off immediately. Ultrasonic scanning equipment. Care and handling of components. Confirm implant locations and scan requirements for the patients system. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Consumer goods and electronic devices. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Use extreme care to not damage the lead with the sharp point of the tunneling tool. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Patients should not be dependent on drugs and should be able to operate the neurostimulation system. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Unauthorized changes to stimulation parameters. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. 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. Generator disposal. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Expiration date. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. 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. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS systems(available online atmedical.abbott/manuals). 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. The clinician programmer and patient controller are not waterproof. 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. Pregnancy and nursing. 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 . The system is intended to be used with leads and associated extensions that are compatible with the system. Do not resterilize or reimplant an explanted system for any reason. 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. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Patient selection. 737202011056 v5.0 | Item approved for U.S. use only. 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. Using the tunneling tool. Device modification. Neurosurgery Pain Management Orthopaedic Surgery (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Lead movement. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. In rare cases, this can create a medical emergency. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Case damage. Magnetic resonance imaging (MRI). 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). Failure to do so may result in damage to the sheath. After defibrillation, confirm the neurostimulation system is still working. Multiple leads. 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. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. 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). Return all explanted components to Abbott Medical for safe disposal. Clinician training. 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. Lead handling. Exposure to body fluids or saline. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Electrosurgery. Clinician training. Patients should cautiously approach such devices and should request help to bypass them. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Ensure the patients neurostimulation system is in MRI mode. 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. Needle positioning. The effect of mobile phones on deep brain stimulation is unknown. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. Generators contain batteries as well as other potentially hazardous materials. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death.
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