Explosive or flammable gasses. Component manipulation by patients. Infection. 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. Interference with wireless equipment. 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. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Patient's visual ability to read the patient controller screen. External defibrillators. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Sheath insertion warning. If the patient requires a CT scan, all stimulation should be turned off before the procedure. 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. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). 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). Infection. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. 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. 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. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. 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. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. Device components. 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. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Implantation of multiple leads. Device modification. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Damage to the system may not be immediately detectable. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Scuba diving or hyperbaric chambers. Risk of depression, suicidal ideations, and suicide. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. High-output ultrasonics and lithotripsy. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. 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.
Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers ), 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.). 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. 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. Generator disposal. Therapeutic radiation. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan.
Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS 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,. Package or component damage. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. Pregnancy and nursing. Electromagnetic interference (EMI). High-output ultrasonics and lithotripsy. 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 safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Do not suture directly onto the lead to avoid damaging the lead. 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. Confirm the neurostimulation system is functioning. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. See Full System Components below if the patient has an IPG and extensions implanted. Equipment is not serviceable by the customer. Product materials. Lasting Relief through our smallest system yet. Always perform removal with the patient conscious and able to give feedback. To prevent injury or damage to the system, do not modify the equipment.
IMAGINE A FUTURE - cloud.neuroemail.abbott.com If radiation therapy is required, the area over the implanted IPG should be shielded with lead. If lithotripsy must be used, do not focus the energy near the IPG. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Poor surgical risks. If multiple leads are implanted, leads and extensions should be routed in close proximity. Security, antitheft, and radiofrequency identification (RFID) devices. Conditional 5. If lithotripsy must be used, do not focus the energy near the IPG. 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. Only apply software updates that are published directly by Abbott Medical. While charging the generator, patients may perceive an increase in temperature at the generator site. Return any suspect components to Abbott Medical for evaluation. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Output power below 80 W is recommended for all activations. Consumer goods and electronic devices. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Read this section to gather important prescription and safety information. Surgical advice for removal. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. 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. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Programmer and controller devices are not waterproof. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. 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. Securing the lead with the lead stabilizer will mitigate this risk. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. 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. Care and handling of components. Low frequencies. Infections related to system implantation might require that the device be explanted. 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. Removing each item in slow movements while holding the remaining components in place will assist this process. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Security, antitheft, and radiofrequency identification (RFID) devices. Mobile phones. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Explosive and flammable gasses. 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. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Failure to provide strain relief may result in lead migration requiring a revision procedure. Battery care. Patients should be advised to not use therapeutic magnets. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems.
Instructions for Use Website - SJM Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. 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. Therapeutic magnets. 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). 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. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Operation of machines, equipment, and vehicles. Clinician training. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems.
Abbott Launches the World's Smallest Implantable, Rechargeable Spinal After defibrillation, confirm the neurostimulation system is still working. 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. 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. 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. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. IPG placement. The implanted components of this neurostimulation system are intended for a single use only. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Keep them dry to avoid damage. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.
MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott Component manipulation by patient. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Securing the anchor. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. 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. The Proclaim XR SCS system can provide relief to . 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation 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. IPGs contain batteries as well as other potentially hazardous materials. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. 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. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Electrical medical treatment. Damage to shallow implants. If two systems are implanted, ensure that at least 20 cm (8 in.)
MR safety: spinal cord stimulators - Questions and Answers in MRI However, some patients may experience a decrease or increase in the perceived level of stimulation. This damage could result in loss of therapy, requiring additional surgery for system replacement. Case damage. 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Always perform removal of implanted components with the patient conscious and able to give feedback. Failure to do so may result in damage to the sheath. 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. 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, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves Store components and their packaging where they will not come in contact with liquids of any kind. Patients should cautiously approach such devices and should request help to bypass them. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.
FDA approves new MRI compatibility for Abbott's Proclaim spinal cord The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. If needed, return the equipment to Abbott Medical for service. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. All components listed must be implanted unless noted as "optional."
FDA Expands MRI Compatibility With Spinal Stimulation for Pain Providing strain relief. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. 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.
Reducing the Pains of Chronic Pain Treatment | Abbott Newsroom Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Scuba diving or hyperbaric chambers. 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. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. This neurostimulation system is contraindicated for patients who are. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths.
Proclaim XR SCS System If two systems are implanted, ensure that at least 20 cm (8 in.) To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. 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. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement.