Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Implanted cardiac systems. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Set the electrosurgery device to the lowest possible energy setting.Ĭonfirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Confirm the neurostimulation system is functioning correctly after the procedure.Ĭomplete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.Įlectrosurgery. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.ĭiathermy is further prohibited because it may also damage the neurostimulation system components. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. 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.ĭiathermy therapy. Physicians should also discuss any risks of MRI with patients. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. Poor surgical risks. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. The following warnings apply to this neurostimulation system. 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.įor 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).įor more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Indications For UseĪbbott Medical spinal cord stimulation (SCS) systems are 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, nonsurgical back pain (without prior surgery and not a candidate for back surgery), and diabetic peripheral neuropathy of the lower extremities. The system is intended to be used with leads and associated extensions that are compatible with the system. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Spinal Column Stimulation (SCS) Systems Intended Use
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