Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems

Inclusion Criteria:

• Are implanted with one of the following SJM device/lead combinations evaluated in thisstudy for at least 60 days (can include patients with an eligible SJM lead for ≥ 60days OR patients with a new eligible SJM pacemaker, ImplantableCardioverter-Defibrillators (ICD), or Cardiac Resynchronization Therapy Defibrillators (CRT-D) device and eligible SJM lead implanted for at least 60 days:

1. Accent MRI™, Assurity MRI™, Endurity MRI™, or Endurity pacemaker with Tendril™STS Model 2088 lead

2. Accent MRI™, Assurity MRI™, Endurity MRI™, or Endurity pacemaker with IsoFlex™Optim (Model 1944 or 1948) lead

3. Ellipse™ VR/DR or Fortify Assura VR/DR ICD with Tendril™ STS (Model 2088) orTendril MRI™ and Durata™ or Optisure™ leads

4. Quadra Assura™ CRT-D with Tendril™ STS (Model 2088), Durata™ or Optisure™, andQuartet™ Quadripolar leads

• Are implanted with an eligible SJM pacemaker, ICD, or CRT-D device pectorally

• Be willing to undergo an elective MRI scan without sedation. Note: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the subject can communicatewith site personnel during the MRI scan

• Be able to provide informed consent for study participation (legal guardian is NOTacceptable)

• Be willing and able to comply with the prescribed follow-up tests and schedule ofevaluations

Exclusion Criteria:

• Have another existing active implanted medical device, e.g., neurostimulator, infusionpump, etc. that has MR labeling that will not allow the MRI scans per this protocol tobe completed.

• Have other non-MRI compatible device or material implanted

• NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may beincluded as long as the labeling of these devices allow MRI scans conducted perthis protocol

• NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves maybe included as long as the labeling of these devices allow for MRI scansconducted per this protocol

• NOTE: Non-removable dental implants may be included

• Have a lead extender, adaptor, or capped/abandoned lead

• Be unable to fit in MRI bore, i.e., subject will come into contact with the magnetfaçade inside the MRI bore.

• Are currently participating in a clinical investigation that includes an activetreatment arm

• Are pregnant or planning to become pregnant during the duration of the study

• Have a life expectancy of less than 3 months due to any condition

• Meet exclusion criteria per local law (e.g. age)