abbott proclaim spinal cord stimulator mri safety

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. Package or component damage. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Keep programmers and controllers dry. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Sheath rotation. Explosive and flammable gasses. Advise patients about adverse effects. 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. All components listed must be implanted unless noted as "optional." Control of the patient controller. 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. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Sheath insertion warning. Thorough psychiatric screening should be performed. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. To prevent injury or damage to the system, do not modify the equipment. 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. Implantation of two systems. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. 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. 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. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Patients should cautiously approach such devices and should request help to bypass them. Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. 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. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Operation of machines, equipment, and vehicles. This equipment is not serviceable by the customer. High-output ultrasonics and lithotripsy. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Cremation. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Return any suspect components to Abbott Medical for evaluation. 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. Application modification. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. 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. 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. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Mobile phones. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy 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. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Pediatric use. This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II.**. Pediatric use. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. 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. 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. 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. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Always perform removal of implanted components with the patient conscious and able to give feedback. Ensure the patients neurostimulation system is in MRI mode. Patients should cautiously approach such devices and should request help to bypass them. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. Security, antitheft, and radiofrequency identification (RFID) devices. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Diathermy is further prohibited because it may also damage the neurostimulation system components. This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. Do not use excessive pressure when injecting through the sheath. 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Electromagnetic interference (EMI). Securing the anchor. An expiration date (or use-before date) is printed on the packaging. 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. Only apply software updates that are published directly by Abbott Medical. Electromagnetic interference (EMI). Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. 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. 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. Output power below 80 W is recommended for all activations. Lead movement. Unauthorized changes to stimulation parameters. 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. Patients should cautiously approach such devices and should request help to bypass them. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. 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. Pain is not resolved. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. To prevent unintended stimulation, do not modify the operating system in any way. Package or component damage. 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. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Placing the IPG. Read this section to gather important prescription and safety information. Excessive lead migration may require reoperation to replace the leads. Wireless use restrictions. All components listed must be implanted unless noted as "optional." 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). Using surgical instruments. 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.). 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. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Lasting Relief through our smallest system yet. Risk of depression, suicidal ideations, and suicide. Unwanted changes in stimulation may include a jolting or shocking feeling. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Return any suspect components to Abbott Medical for evaluation. Use extreme care to not damage the lead with the sharp point of the tunneling tool. A recharge-by date is printed on the packaging. In rare cases, this can create a medical emergency. Surgical advice for removal. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator.

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