SJM Brady MRI Post Approval Study

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.

Note: Only the Accent MRI pacemaker has not been approved by the FDA for market release.
Former IDE patients implanted with the Accent MRI pacemaker are approved to rollover into
this PAS. No new implants with the Accent MRI pacemaker will be enrolled.

Inclusion Criteria:

1. Subject is able to provide informed consent for study participation (legally
authorized representative is NOT acceptable).

2. Subject is at least 18 years of age or of legal age to give informed consent specific
to state and national law.

3. Subject meets at least one of the following criteria:

1. Is an Accent MRI IDE study subject who is being rolled over into the SJM Brady
MRI PAS and still has at least one Tendril MRI™ lead implanted with a SJM Brady
MRI pacemaker such as the Accent MRI or similar model.

2. Is a subject who has been implanted with at least one Tendril MRI lead and a SJM
Brady MRI pacemaker such as the Accent MRI or similar model, but is not part of
the Accent MRI IDE study and will be enrolled within 30 days after implant.

3. Is a subject who will be implanted with at least one Tendril MRI lead and a SJM
Brady MRI pacemaker such as the Accent MRI or similar model and will be consented
either at or within 30 days before implant.

4. Subject is willing and able to comply with the prescribed follow-up tests and schedule
of evaluations including MRI scan procedures.

Exclusion Criteria:

1. Subject has been enrolled or intends to participate in a clinical drug and/or device
study with an active treatment arm or that has any procedures, which could confound
the results of this trial.

2. Subject is not expected to be able to complete the study follow up schedule or
duration due to any health condition such as has malignancy, is deemed a candidate for
transplant or Ventricular Assist Device, or in hospice care.