New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Risk of depression, suicidal ideations, and suicide. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet.ĭiathermy therapy. 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. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. For more information, see the clinician programmer manual. Charge density can be reduced by lowering the stimulation amplitude or pulse width. If the programming of stimulation parameters exceeds the charge density limit of 30 μC/cm2, a screen will appear warning you that the charge density is too high. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. High stimulation outputs and charge density limits. 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. 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. Patients should not use this neurostimulation system if they are pregnant or nursing. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. The following warnings apply to this neurostimulation system. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/MRI-ready. 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. 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 to inform their healthcare professional that they cannot undergo the following procedures:ĭiathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy)Įlectroshock therapy and transcranial magnetic stimulation (TMS) The following procedures are contraindicated for patients with a deep brain stimulation system. This system is contraindicated for patients who meet the following criteria: Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.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 Parkinson’s disease that are not adequately controlled by medications.The Abbott Medical deep brain stimulation system is indicated for the following conditions: 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. Deep Brain Stimulation (DBS) Therapy Intended Use
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