ProMRI Study of the Entovis Pacemaker System

Inclusion Criteria:

The following initial inclusion criteria must be met for a subject to be enrolled and
considered for the MRI-procedure:

- Age greater than 18 years

- Subject body height greater than 140 cm (4' 7")

- Able and willing to complete MRI testing

- Able to provide written informed consent

- Available for follow-up visit at the study site

- Implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T,
SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s). (No leads other
than Setrox S (53 or 60 cm) leads may be implanted. This includes lead extensions or
abandoned leads in the subject.)

- Pacemaker implanted pectorally

- All pacemaker system components implanted, repositioned, or exchanged at least 5
weeks prior to enrollment

- Underling rhythm identifiable during sensing test

- All pacing thresholds are measureable and are less than or equal to 2.0 V @0.4 ms

- Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms

- Pacing impedance is between 200 and 1500 ohm

- Able and willing to use the Cardio Messenger

At the pre-MRI procedure, the following procedure-related criteria must be met for the
subject to undergo the MRI scan:

- Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms

- /pacing threshold at Pre-MRI follow-up - pacing threshold at baseline/ ≤ 0.5 V

- All pacing thresholds are measureable and are ≤ 2.0 V @ 0.4 ms

- The pacemaker system has been implanted for at least 6 weeks.

- Subject did not have a pacemaker or lead explant, exchange or reposition in the
previous 6 weeks.

- All lead impedances are between 200 and 1500 ohm.

- Battery status is at least 30% of capacity

Exclusion Criteria:

- Enrolled in any other clinical study

- For pacemaker systems that include an atrial lead, subjects with either

- Persistent atrial arrhythmia (lasting longer than 7 days or requiring
cardioversion)

- Permanent atrial arrhythmia

- Life expectancy of less than three months

- Pregnancy

- Cardiac surgery expected in the next three months

- Implanted with other medical devices that may interact with MRI, such as:

- abandoned pacemaker/ICD leads

- lead extensions

- mechanical valves

- other active medical devices

- non-MRI compatible devices

- other metallic artifacts/components in body that may interact with MRI