Security, antitheft, and radiofrequency identification (RFID) devices. separates the implanted IPGs to minimize unintended interaction with other system components. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. 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. During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. Risk of depression, suicidal ideations, and suicide. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Package or component damage. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Scuba diving or hyperbaric chambers. Object Info: - MRI Safety Follow proper infection control procedures. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Lead damage from tools. Securing the anchor. 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. 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. 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. The placement of the leads involves some risk, as with any surgical procedure. High-output ultrasonics and lithotripsy. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. 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. Inaccurate ECG results may lead to inappropriate treatment of the patient. communication equipment (such as microwave transmitters and high-power amateur transmitters). Why Proclaim XR SCS System - Abbott 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. 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. Preventing infection. 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. Unauthorized changes to stimulation parameters. Case damage. 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. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. 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. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Device components. Component disposal. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Placing the IPG. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). 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. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Sheath insertion warning. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. 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 following warnings apply to this neurostimulation system. Detailed information on storage environment is provided in the appendix of this manual. Infections may require that the device be explanted. Stimulation Modes. This damage could result in loss of therapy, requiring additional surgery for system replacement. Conscious sedation. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Multiple leads. 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. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Poor surgical risks. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. 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). Confirm implant locations and scan requirements for the patients system. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Patients should cautiously approach such devices and should request help to bypass them. 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. 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. Follow proper infection control procedures. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Abandoned leads and replacement leads. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. 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. *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. Use care when reinserting a stylet. Back pain. For this reason, programming at frequencies less than 30 Hz is not recommended. Package or component damage. If interference occurs, try holding the phone to the other ear or turning off the phone. Scuba diving or hyperbaric chambers. 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. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Neurosurgery Pain Management Orthopaedic Surgery Do not use the system if the use-before date has expired. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Always perform removal with the patient conscious and able to give feedback. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Exit Surgery mode during intraoperative testing and after the procedure is completed. 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. Lead movement. After defibrillation, confirm the neurostimulation system is still working. 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. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Sheath rotation. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Component disposal. FDA Approves Abbott's Spinal Cord Stimulation for People Living with These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Recharge-by date. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. 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. 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. Exposure to body fluids or saline. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Security, antitheft, and radiofrequency identification (RFID) devices. IPGs contain batteries as well as other potentially hazardous materials. Consumer goods and electronic devices. See Full System Components below if the patient has an IPG and extensions implanted. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. In rare cases, this can create a medical emergency. Proclaim XR SCS System For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Return any suspect components to Abbott Medical for evaluation. Pregnancy and nursing. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Patients should cautiously approach such devices and should request help to bypass them. Failure to do so may cause harm to the patient such as damage to the dura. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. 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 dry to avoid damage. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Anchoring leads. Device modification. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. To prevent injury or damage to the system, do not modify the equipment. Lead handling. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Explosive and flammable gasses. 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. 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. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, 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, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. Deep brain stimulation complications include, but are not limited to, the following: Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture, Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture, Initial jolt or tingling during stimulation; jolting or shocking sensations, Lead fracture, migration, or dislodgement, Extension malfunction, fracture, or disconnect, Deep brain stimulation system failure or battery failure within the device, Deep brain stimulation system malfunction or dislodgement, Allergic or rejection response to implanted materials, Persistent pain, tightness, or redness at the incision sites or general pain, General erosion or local skin erosion over the IPG, Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck), Impaired wound healing (e.g., incision site drainage) or abscess formation, Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component, Stimulation-related complications or other complications, Worsening of motor impairment and Parkinsons disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia, Paresis, asthenia, hemiplegia, or hemiparesis, Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance, Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia, Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium, Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope), Eye disorder including eye apraxia or blepharospasm, (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. Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinsons disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI. Do not crush, puncture, or burn the IPG because explosion or fire may result. Return all explanted generators to Abbott Medical for safe disposal. Changes in blood glucose levels in response to any adverse effect Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. IMAGINE A FUTURE - cloud.neuroemail.abbott.com Scuba diving and hyperbaric chambers. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Lead movement. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. Removing a kinked sheath. Programmer and controller devices are not waterproof. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott External defibrillators. FDA approves new MRI compatibility for Abbott's Proclaim spinal cord 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. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Component manipulation. Return of symptoms and rebound effect. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Confirm the neurostimulation system is functioning correctly after the procedure. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Needle insertion. Other active implantable devices. 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. Electromagnetic interference (EMI). 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. radiofrequency identification (RFID) devices. Operation of machinery and equipment. Spinal Cord Stimulator Systems - Boston Scientific 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. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. The following precautions apply to this neurostimulation system. A recharge-by date is printed on the packaging. Patients should not be dependent on drugs and should be able to operate 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. Mobile phones. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. away from the generator and avoid placing any smart device in a pocket near the generator. 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. Patients should exercise reasonable caution when bathing. 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. Consider seeking surgical advice if you cannot easily remove a lead. Postural changes. Pediatric use. Patients should be advised to not use therapeutic magnets. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. 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. Storage environment. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. 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). Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. Clinician training. Operating the device near gas fumes or vapors could cause them to catch fire. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. 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. High stimulation outputs and charge density limits. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Failure to do so may result in difficulty delivering the lead. Removing components. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. ** Neurostimulation systems have materials that come in contact or may come in contact with tissue. 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.
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