Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. 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. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Neurosurgery Pain Management Orthopaedic Surgery Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. 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. 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. January 4, 2022 By Sean Whooley. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. 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. Do not use surgical instruments to handle the lead. Wireless use restrictions. 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. 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. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. 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. Stabilizing the lead during insertion. The IPG should be explanted before cremation because the IPG could explode. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Unwanted changes in stimulation may include a jolting or shocking feeling. This neurostimulation system is contraindicated for patients who are. 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. Confirm the neurostimulation system is functioning. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Neuromodulation. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Suicidal ideation, suicide attempts, and suicide are events that have also been reported. 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 and intractable low back and leg pain. Electrosurgery. Detailed information on storage environment is provided in the appendix of this manual. Follow proper infection control procedures. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Only apply software updates that are published directly by Abbott Medical. Risk of depression, suicidal ideations, and suicide. Electromagnetic interference (EMI). 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. 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. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Case damage. 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. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Therapeutic radiation. separates the implanted IPGs to minimize unintended interaction with other system components. 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). Unauthorized changes to stimulation parameters. 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. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. 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. 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. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Package or component damage. Patient training. The system is intended to be used with leads and associated extensions that are compatible with the system. Case damage. Placing the IPG. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Package or component damage. 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. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. ), 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.). If unpleasant sensations occur, turn off stimulation immediately. Restricted areas. The placement of the leads involves some risk, as with any surgical procedure. Needle insertion. Before reinserting the sheath, verify there is no damage to the sheath. Emergency procedures. 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. 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. ** Interference with wireless equipment. Operating the device near gas fumes or vapors could cause them to catch fire. Patients should exercise reasonable caution when bathing. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) away from the generator and avoid placing any smart device in a pocket near the generator. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Care and handling of components. 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. away from the generator and avoid placing any smart device in a pocket near the generator. 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. Explosive and flammable gasses. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. External defibrillators. After defibrillation, confirm the neurostimulation system is still working. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Device components. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Component handling. 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. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 2013;16(5):471-482. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Device modification. 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), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). Additional Disadvantages. 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. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Inserting the anchor. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. 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. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. 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. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. Exposure to body fluids or saline. Implantation of multiple leads. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. **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.
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