abbott proclaim spinal cord stimulator mri safety

If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Securing the IPG. An expiration date (or use-before date) is printed on the packaging. Output power below 80 W is recommended for all activations. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Computed tomography (CT). Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. Thorough psychiatric screening should be performed. Implantation at vertebral levels above T10. 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. 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). If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. If radiation therapy is required, the area over the implanted generator should be shielded with lead. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. 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. Confirm that no adverse conditions to MR scanning are present. Do not use the application if the operating system is compromised (that is, jailbroken). The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. 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 and induce voltage through the lead that could jolt or shock the patient. Bathing. Inserting the anchor. Do not resterilize or reimplant an explanted system for any reason. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Monitor the patients blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. 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. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. 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. Store components and their packaging where they will not come in contact with liquids of any kind. This equipment is not serviceable by the customer. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. After defibrillation, confirm the neurostimulation system is still working. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Component handling. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. If unpleasant sensations occur, the device should be turned off immediately. IPG placement. 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. Proclaim XR SCS System Meaningful relief from chronic pain. Return any suspect components to Abbott Medical for evaluation. 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. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. The system is intended to be used with leads and associated extensions that are compatible with the system. Component manipulation by patient. Security, antitheft, and radiofrequency identification (RFID) devices. Pregnancy and nursing. Keep programmers and controllers dry. 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. ), 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.). Implanting physicians should be experienced in stereotactic and functional neurosurgery. Always perform removal with the patient conscious and able to give feedback. 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). Set the electrosurgery device to the lowest possible energy setting. Neuromodulation. INDICATIONS FOR USE However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. Free from the hassles of recharging. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. 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. Devices with one-hour recharge per day. 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. 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. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. Application modification. 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. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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. A recharge-by date is printed on the packaging. 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. Learn more about the scan details for our MR Conditional products below. 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. 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. Skydiving, skiing, or hiking in the mountains. 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. Lead movement. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. ** Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 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. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. 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. Physicians should also discuss any risks of MRI with patients. Skin erosion. Wireless use restrictions. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) 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. All components listed must be implanted unless noted as "optional." Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Up to two leads, lead protection boots, and burr hole covers may be implanted. Wireless use restrictions. Care and handling of components. 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). The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Pediatric use. Storage environment. maximize the distance between the implanted systems; Use in patients with diabetes. 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. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. 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. External defibrillators. This may occur once the lead is in place and is connected to the neurostimulator and activated. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. Scanning under different conditions may cause device malfunction, severe patient injury, or death. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. 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. Placing the IPG. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Physicians should also discuss any risks of MRI with patients. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. Nerve damage may result from traumatic or surgical nerve injury. 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. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Pregnancy and nursing. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Interference with wireless equipment. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. Stabilizing the lead during insertion. To prevent injury or damage to the system, do not modify the equipment. Infection. To prevent unintended stimulation, do not modify the operating system in any way. Use extreme care when handling system components. 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. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Long-term safety and effectiveness. Surgical advice for removal. 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. 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. Package or component damage. Placement of lead connection in neck. 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. The implanted components of this neurostimulation system are intended for a single use only. Transcutaneous electrical nerve stimulation (TENS). Bending the sheath. 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. 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). 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. Damage to the system may not be immediately detectable. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Conditional 5. Do not crush, puncture, or burn the generator because explosion or fire may result. Always be aware of the needle tip position. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Programmer and controller devices are not waterproof. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Do not crush, puncture, or burn the IPG because explosion or fire may result. 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. Remove the stylet from the lead only when satisfied with lead placement. Failure to do so can damage or cut the lead or sheath. Infection. If two systems are implanted, ensure that at least 20 cm (8 in.) Use extreme care when handling system components prior to implantation. Patients should cautiously approach such devices and should request help to bypass them. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. 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). Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Generators contain batteries as well as other potentially hazardous materials. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Infections related to system implantation might require that the device be explanted. Component disposal. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. 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. Excessive lead migration may require reoperation to replace the leads. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. 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). Interference with other devices. Postural changes. Operation of machines, equipment, and vehicles. 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. The force of the instruments may damage the lead or stylet. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Generator disposal. Patients should cautiously approach such devices and should request help to bypass them. Use caution when sedating the patient.

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