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The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).
The proportion of patients implanted with an MR Conditional CIED System with a pre-MRI to post-MRI scan PCT measure change of >0.5 Volts following 3T MRI scan exposure. [ Time Frame: Patients will be followed for approximately 5 years. ]
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients intended to be implanted or are within 30 days post-implant of a qualifying Medtronic 3T MR Conditional CIED system. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Subject is intended to be implanted or is within 30 days post-implant of a qualifying Medtronic 3T MR Conditional CIED system
Subject who is, or will be inaccessible for follow-up at a study site
Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable