SJM Brady MRI Post Approval Study
SJM Brady MRI Post Approval Study
The purpose of this post approval study is to evaluate the long-term safety of the FDA approved St. Jude Medical Tendril MRI™ lead implanted with a SJM Brady MRI implantable pulse generator (IPG) such as the Accent MRI™, Assurity MRI™, Endurity MRI™ pacemaker, or similar model (SJM Brady MRI System) in subjects with a standard bradycardia pacing indication.
This is a prospective, multi-center clinical study designed to evaluate the long-term safety of the Tendril MRI™ lead implanted with any SJM Brady MRI pacemaker or similar model (SJM Brady MRI system) in subjects with a standard bradycardia pacing indication through 60 months of follow up.
Additionally, the study will assess the safety of the pacemaker system in subject(s) undergoing clinically indicated MRI scan(s). Any enrolled subject implanted with the SJM Brady MRI system may be included in this evaluation if they are scheduled for or planning to have a MRI scan during the course of the study.
Inclusion Criteria:
Subject is able to provide informed consent for study participation (legally authorized representative is NOT acceptable).
Subject is at least 18 years of age or of legal age to give informed consent specific to state and national law.
Subject meets at least one of the following criteria:
Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations including MRI scan procedures.
Exclusion Criteria:
San Diego, California 92103, United States