Skin erosion. Keep them dry to avoid damage. Explosive and flammable gasses. High-output ultrasonics and lithotripsy. Back pain. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). 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. Return all explanted IPGs to Abbott Medical for safe disposal. 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. Removing each item in slow movements while holding the remaining components in place will assist this process. Do not suture directly onto the lead to avoid damaging the lead. Storage environment. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. A summary of the safety and clinical performance (SSCP) for these devices will be published at https://ec.europa.eu/tools/eudamed by the Notified Bodies in accordance with the requirements of EU MDR 2017/745 and associated timelines. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Postural changes. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Return all explanted components to Abbott Medical for safe disposal. IPG placement. 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. Mobile phones.
Getting an MRI | Medtronic Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers.
Proclaim XR SCS System Confirm implant locations and scan requirements for the patients system. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. The Proclaim XR SCS system can provide relief to . Device modification. Return all explanted components to Abbott Medical for safe disposal. Use extreme care to not damage the lead with the sharp point of the tunneling tool. 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. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Wireless use restrictions. 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. 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 safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. 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. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Remove leads slowly. High stimulation outputs and charge density limits. For more information, see the clinician programmer manual. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. Always perform removal with the patient conscious and able to give feedback. 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. 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. Stylet handling. The device should be turned off and the doctor contacted if this occurs. 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).
MR safety: spinal cord stimulators - Questions and Answers in MRI and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Return any suspect components to Abbott Medical for evaluation. 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. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. External defibrillators. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. If lithotripsy must be used, do not focus the energy near the IPG. Wireless use restrictions. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. 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. 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. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Implantation of multiple leads. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Changes in blood glucose levels in response to any adverse effect
Patients should be advised to not use therapeutic magnets. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Devices with one-hour recharge per day. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. If interference occurs, try holding the phone to the other ear or turning off the phone. Follow proper infection control procedures. 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. Our Invisible Trial System TM is a discreet, app . Return any suspect components to Abbott Medical for evaluation. 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.). ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. 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. Neurostimulation should not be used on patients who are poor surgical candidates. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Damage to the system may not be immediately detectable. Conscious sedation during removal. Implantation of multiple leads. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. 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. 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. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Failure to do so can damage or cut the lead or sheath. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. 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. Implanting physicians should be experienced in stereotactic and functional neurosurgery. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Number of leads implanted. Exit Surgery mode during intraoperative testing and after the procedure is completed. 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. 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. If needed, return the equipment to Abbott Medical for service. 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. System testing. Device modification. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. The following warnings apply to this neurostimulation system. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. 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. Proclaim XR SCS System Meaningful relief from chronic pain. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Do not crush, puncture, or burn the generator because explosion or fire may result. 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. Lasting Relief through our smallest system yet. 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). Return all explanted generators to Abbott Medical for safe disposal. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator.
FDA approves new MRI compatibility for Abbott's Proclaim spinal cord 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. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. 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. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Implant heating. Read this section to gather important prescription and safety information. Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. Mobile phones. 737202011056 v5.0 | Item approved for U.S. use only.
MRI Support | Abbott Neuromodulation Consumer goods and electronic devices. Poor surgical risks. Implantation of two systems. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Free from the hassles of recharging. Scuba diving or hyperbaric chambers. The system is intended to be used with leads and associated extensions that are compatible with the system. High stimulation outputs. Case damage. Neurosurgery Pain Management Orthopaedic Surgery 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. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. 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. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. 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. 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). Component manipulation. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. 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). Failure to provide strain relief may result in lead migration requiring a revision procedure. Diathermy is further prohibited because it may also damage the neurostimulation system components.
Instructions for Use Website - SJM Proclaim Plus: The Next Burst in Chronic Pain Care | Abbott Newsroom Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Abandoned leads and replacement leads. Ensure the patients neurostimulation system is in MRI mode. 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. 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. Keep them dry to avoid damage. Anchoring leads. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. 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. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Loss of coordination is a potential side effect of DBS therapy. Stimulation Modes. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Security, antitheft, and radiofrequency identification (RFID) devices. Pregnancy and nursing.
Disadvantages and Risks of Spinal Cord Stimulation The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Infections may require that the device be explanted. Schu S, Gulve A, ElDabe S, et al. 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). Advise patients about adverse effects. 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. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Advancing components. 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. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Infections related to system implantation might require that the device be explanted. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Providing strain relief. Sheath insertion precaution. Electrocardiograms. Lead movement. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. 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. 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. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Patient selection. Equipment is not serviceable by the customer. 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. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. The implanted components of this neurostimulation system are intended for a single use only. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Bending the sheath. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. FDA's expanded . between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance. If multiple leads are implanted, leads and extensions should be routed in close proximity. Lead movement. ), 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.). Operating the device near gas fumes or vapors could cause them to catch fire.
Proclaim DRG System | Abbott 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. Case damage. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. 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. To prevent injury or damage to the system, do not modify the equipment. 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. Overcommunicating with the IPG. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Do not use the application if the operating system is compromised (that is, jailbroken). Return any suspect components to Abbott Medical for evaluation. It is extremely important to select patients appropriately for neurostimulation. Component manipulation by patient. separates the implanted generators to minimize unintended interaction with other system components. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). The force of the instruments may damage the lead or stylet. Surgical advice for removal. Case damage. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Select patients appropriately for deep brain stimulation. Implantation of two systems. Confirm that no adverse conditions to MR scanning are present. Placing the IPG. 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. Patients should cautiously approach such devices and should request help to bypass them. Keep the device dry. 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. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura.