Consumer goods and electronic devices. Radiofrequency or microwave ablation. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Use extreme care when handling system components.
Abbott - Spinal Cord Stimulation 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). These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Patients should be advised to not use therapeutic magnets. The implanted components of this neurostimulation system are intended for a single use only. If unpleasant sensations occur, turn off stimulation immediately. Patient selection. If the stylet is removed from the lead, it may be difficult to reinsert it. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Our Invisible Trial System TM is a discreet, app . Storage environment. Electromagnetic interference (EMI). The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Long-term safety and effectiveness. Select patients appropriately for deep brain stimulation. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Infection. 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. Wireless use restrictions. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Loss of coordination is a potential side effect of DBS therapy. Conscious sedation. Patients should cautiously approach such devices and should request help to bypass them. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). 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. 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. All components listed must be implanted unless noted as "optional." Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Remove leads slowly. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. If two systems are implanted, ensure that at least 20 cm (8 in.) Use caution when sedating the patient. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. six to eight weeks after implantation of a neurostimulation system. Electromagnetic interference (EMI). The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Failure to do so may result in difficulty delivering the lead. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Product materials. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Control of the patient controller. Skin erosion. Pediatric use. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. 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. The safety and effectiveness of neurostimulation for pediatric use have not been established. 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. 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. 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. 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). Follow proper infection control procedures. Confirm implant locations and scan requirements for the patients system. Equipment is not serviceable by the customer. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. 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. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. 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. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. Other active implantable devices. 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. Poor surgical risks. Removing each item in slow movements while holding the remaining components in place will assist this process. Lead insertion through sheath. Patients should exercise reasonable caution when bathing. Schu S, Gulve A, ElDabe S, et al. 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.
FDA approves new MRI compatibility for Abbott's Proclaim spinal cord Securing the anchor. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. INDICATIONS FOR USE Pregnancy and nursing. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. The Eterna SCS 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 website that you have requested also may not be optimized for your screen size. Cremation. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Activities requiring coordination. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. Pregnancy and nursing. The system is intended to be used with leads and associated extensions that are compatible with the system. 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. Neuromodulation. Patients who are unable to properly operate the system. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Overcommunicating with the IPG. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Remove the stylet from the lead only when satisfied with lead placement.
MR safety: spinal cord stimulators - Questions and Answers in MRI Object Category Spinal Cord Stimulation Systems: St. Jude Medical. 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. Sheath rotation. 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. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement.
Device profile of the Proclaim XR neurostimulation system for the The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Return all explanted IPGs to Abbott Medical for safe disposal. FDA's expanded . The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Operation of machines, equipment, and vehicles. If two systems are implanted, ensure that at least 20 cm (8 in.) The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Patients should cautiously approach such devices and should request help to bypass them. 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.
Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS Patients should cautiously approach such devices and should request help to bypass them. Package or component damage. Patient selection. Needle positioning. 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. Security, antitheft, and radiofrequency identification (RFID) devices. Activities requiring excessive twisting or stretching. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Avoid placing equipment components directly over other electronic devices. Application modification. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). 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. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. IPGs contain batteries as well as other potentially hazardous materials. 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. Ultrasonic scanning equipment. Patient training. Surgical advice for removal. For this reason, programming at frequencies less than 30 Hz is not recommended. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. 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. If lithotripsy must be used, do not focus the energy near the IPG. Device modification. 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.
MRI Support | Abbott Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Diathermy is further prohibited because it may also damage the neurostimulation system components. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. 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.