Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment

Exclusion Criteria

• •Subjects with a mechanical tricuspid heart valve.
• •Subjects with a history of significant tricuspid valvular disease.
• •Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
• •Subjects who require a legally authorized representative to obtain consent.
• •Subjects who have abandoned (inactive) pacemaker and/or defibrillator leads
• •Subjects who are immediate candidates for an ICD.
• •Subjects who require an indicated MRI scan, other than those specifically described in the study, before the one-month post MRI/waiting period follow-up.
• •Subjects with previously implanted active medical devices (exception Model 5076 Lead and Advisa MRI IPG).
• •Subjects with a non-MRI compatible device (such as ICDs or neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
• •Subjects with medical conditions that preclude the testing required by the protocol or limit study participation.
• •Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during this clinical study.
• •Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.