Imageready Mr Conditional Pacing System Full System Are
The INGEVITY trial, a prospective, non-randomized study, enrolled 1,036 patients and assessed safety, performance and effectiveness of the leads in patients with a single or dual chamber pacemaker. MR Conditional System Information These leads can be used as part of the ImageReady MR Conditional Pacing System or the ImageReady MR Conditional Defibrillation System (hereafter each referred to as an MR Conditional System) when connected to Boston Scientific ImageReady MR Conditional pulse generators. Patients with an MRAn ImageReady MR Conditional Pacing System consists of specific Boston Scientific model components including pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) pulse generators, leads, accessories, the Programmer, and the Programmer Software Application.Boston Scientific, a global medical technology leader, has received US Food and Drug Administration (FDA) approval for a suite of products deemed safe for use in a magnetic resonance imaging (MRI) environment. The ImageReady MR-Conditional Pacing System, which includes ACCOLADE MRI and ESSENTIO MRI pacemakers, as well as the new INGEVITY MRI pacing leads, is designed to treat bradycardia, a condition in which the heart beats too slowly. Patients implanted with the full system are able to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met.The following symbols are related to the magnetic resonance (MR) environment and are used to indicate the safety of devices and components in the MR environment.
Refer to the Instructions for Use provided with the Vercise DBS System or BostonScientific.com for potential adverse effects, warnings, and precautions prior to using this product.Warnings: Unauthorized modification to the medical devices is prohibited. Monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control and manage appropriately. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy. Assess patients for the risks of depression and suicide.
Strong electromagnetic fields, such as power generators, security screeners or theft detection systems, can potentially turn the stimulator off, or cause unpredictable changes in stimulation. Patients implanted with the Vercise DBS System may be at risk for intracranial hemorrhages (bleeding in the brain) during DBS lead placement. High level of stimulation may damage brain tissue.
The Deep Brain Stimulation System may interfere with the operation of implanted stimulation devices, such as cardiac pacemakers, implanted cardioverter defibrillators, or medication delivery pumps. Chemical burns may result if the Vercise Stimulator housing is ruptured or pierced. If you notice new onset or worsening depression, changes in mood or behavior or impulse control, or have thoughts of suicide contact your physician or emergency services immediately.
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