Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Infection. Confirm the neurostimulation system is functioning. 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. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Stylet handling. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). 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. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Control of the patient controller. 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. While charging the generator, patients may perceive an increase in temperature at the generator site. Case damage. 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. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. IPG disposal. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Lasting Relief through our smallest system yet. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Do not suture directly onto the lead to avoid damaging the lead. 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. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Stimulation effectiveness. If two systems are implanted, ensure that at least 20 cm (8 in.) Do not use excessive pressure when injecting through the sheath. Read this section to gather important prescription and safety information. If interference occurs, try holding the phone to the other ear or turning off the phone. To prevent unintended stimulation, do not modify the operating system in any way. Failure to provide strain relief may result in lead migration requiring a revision procedure. High stimulation outputs and charge density limits. Multiple leads. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Infections may require that the device be explanted. FDA's expanded . Removing components. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Handle the programmers and controllers with care. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. The following warnings apply to this neurostimulation system. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. To prevent unintended stimulation, do not modify the operating system in any way. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. commercial electrical equipment (such as arc welders and induction furnaces). Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Patients who are unable to properly operate the system. System testing. Keep them dry to avoid damage. Wireless use restrictions. After defibrillation, confirm the neurostimulation system is still working. Spinal Cord Stimulator Systems - Boston Scientific Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Exit Surgery mode during intraoperative testing and after the procedure is completed. 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. Conscious sedation during removal. Surgical advice for removal. Implantation of multiple leads. Consumer goods and electronic devices. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Wireless communications equipment, such as mobile and cordless phones and walkie-talkies, may interfere with the IPG if the equipment gets too close to the IPG. Care and handling of components. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Component manipulation by patients. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. 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, near explosives, or in hazardous locations. Scuba diving or hyperbaric chambers. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Use caution when sedating the patient. 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. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Security, antitheft, and radiofrequency identification (RFID) devices. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Do not use the application if the operating system is compromised (that is, jailbroken). This may occur once the lead is in place and is connected to the neurostimulator and activated. Consumer goods and electronic devices. *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. Lead movement. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Securing the IPG. Programmer use. Return them to Abbott Medical for proper disposal. The force of the instruments may damage the lead or stylet. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Neurostimulation should not be used on patients who are poor surgical candidates. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. High-output ultrasonics and lithotripsy. 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). High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Anchoring leads. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Device modification. Make the Bold Choice Infections related to system implantation might require that the device be explanted. 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. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Abandoned leads and replacement leads. Changes in blood glucose levels in response to any adverse effect Operating the device near gas fumes or vapors could cause them to catch fire. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. 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. communication equipment (such as microwave transmitters and high-power amateur transmitters). Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 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). Stimulation effectiveness has been established for one year. Stimulation Modes. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Keep them dry to avoid damage. 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. Placement of lead connection in neck. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. High stimulation outputs. 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). Component disposal. Follow proper infection control procedures. Patients should cautiously approach such devices and should request help to bypass them. Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. Approved models and implant locations for an MR Conditional lead-only system. Disadvantages and Risks of Spinal Cord Stimulation The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. 2013;16(5):471-482. 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. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Safety and effectiveness of neurostimulation for pediatric use have not been established. Electrocardiograms. All components listed must be implanted unless noted as "optional." A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Equipment is not serviceable by the customer. Mobile phones. If the stylet is removed from the lead, it may be difficult to reinsert it. Surgeon training. Electromagnetic interference (EMI). If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Therapeutic magnets. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Infection. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Do not use the application if the operating system is compromised (i.e., jailbroken). 71409MAT-2116350 v4.0 | Item approved for U.S. use only. This neurostimulation system is contraindicated for patients who are. Follow proper infection control procedures. Do not crush, puncture, or burn the IPG because explosion or fire may result. Read this section to gather important prescription and safety information. 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. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers 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,. Storage environment. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. 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. Clinician programmers, patient controllers, and chargers are not waterproof. Remove leads slowly. Damage to the system may not be immediately detectable. If unpleasant sensations occur, the IPG should be turned off immediately. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. 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. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Poor surgical risks. 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. The following precautions apply to this neurostimulation 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. External defibrillators. Conditional 5. 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). Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Failure to do so may cause harm to the patient such as damage to the dura. 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. Removing each item in slow movements while holding the remaining components in place will assist this process. 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. Patient training. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). If patients feel that the TENS device may be interfering with the neurostimulator, patients should discontinue using the TENS device until they talk with their physician. This includes oxygen-enriched environments such as hyperbaric chambers. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. 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. 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. Have the patient check the device for proper functioning, even if the device was turned off. **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. Component handling. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Unwanted changes in stimulation may include a jolting or shocking feeling. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Pain is not resolved. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Application modification. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Inserting the anchor. 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. 737202011056 v5.0 | Item approved for U.S. use only. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Removing a kinked sheath. 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. If unpleasant sensations occur, turn off stimulation immediately. Infections related to system implantation might require that the device be explanted. Electrosurgery. Bold New Spinal Cord Stimulation - Proclaim XR SCS System Scanning under different conditions may cause device malfunction, severe patient injury, or death. Security, antitheft, and radiofrequency identification (RFID) devices. Pregnancy and nursing. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. IPG placement. 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 following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Return any suspect components to Abbott Medical for evaluation. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Devices with one-hour recharge per day. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Wireless use restrictions. Follow proper infection control procedures.
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