Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). 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). If unpleasant sensations occur, the IPG should be turned off immediately. Component manipulation. Programmer and controller devices are not waterproof. Number of leads implanted. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Failure to do so may result in damage to the sheath. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. High stimulation outputs. See Full System Components below if the patient has an IPG and extensions implanted. 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. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Do not use the system if the use-before date has expired. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Damage to shallow implants. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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. Using surgical instruments. communication equipment (such as microwave transmitters and high-power amateur transmitters). Patient activities and environmental precautions. 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. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Surgical advice for removal. Follow proper infection control procedures. Additional Disadvantages. Infections related to system implantation might require that the device be explanted. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. 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. 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. Component handling. Return them to Abbott Medical for proper disposal. Do not use surgical instruments to handle the lead. Do not use the application if the operating system is compromised (that is, jailbroken). Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. If two systems are implanted, ensure that at least 20 cm (8 in.) A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Magnetic resonance imaging (MRI). 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. IPGs contain batteries as well as other potentially hazardous materials. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Application modification. Package or component damage. Neurostimulation should not be used on patients who are poor surgical candidates. Battery care. Multiple leads. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. Security, antitheft, and radiofrequency identification (RFID) devices. ), 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.). Removing each item in slow movements while holding the remaining components in place will assist this process. Package or component damage. 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. Free from the hassles of recharging. Implantation of two systems. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. PATIENTS Patients should cautiously approach such devices and should request help to bypass them. Explosive and flammable gasses. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Lasting Relief through our smallest system yet. The equipment is not serviceable by the customer. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Patients should cautiously approach such devices and should request help to bypass them. Use extreme care to not damage the lead with the sharp point of the tunneling tool. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Keep them dry to avoid damage. Pediatric use. A recharge-by date is printed on the packaging. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. IPG placement. 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. Low frequencies. 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). The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. If needed, return the equipment to Abbott Medical for service. 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.). Consumer goods and electronic devices. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. 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. Anchoring leads. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. 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. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Mobile phones. Securing the anchor. Pregnancy and nursing. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Patient training. 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). Overcommunicating with the IPG. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. 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. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. 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. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. 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. 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. 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. 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. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Patient training. An expiration date (or use-before date) is printed on the packaging. Lead movement. Stylet handling. 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. Keep them dry to avoid damage. 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. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. 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. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Preventing infection. Risk of depression, suicidal ideations, and suicide. Wireless use restrictions. (2) The method of its application or use. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Follow proper infection control procedures. 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. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. 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. 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 exercise reasonable caution when bathing. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. The website that you have requested also may not be optimized for your screen size. Confirm the neurostimulation system is functioning correctly after the procedure. 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). 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. In rare cases, this can create a medical emergency. commercial electrical equipment (such as arc welders and induction furnaces). The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Thorough psychiatric screening should be performed. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. 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. Make the Bold Choice 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. 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. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Confirm the neurostimulation system is functioning. All components listed must be implanted unless noted as "optional." Use caution when sedating the patient. Confirm that no adverse conditions to MR scanning are present. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. 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. 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. 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. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. This neurostimulation system is contraindicated for patients who are. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. 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. Clinician training. 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. **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. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Removing a kinked sheath. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Providing strain relief. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. 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).
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