4968 Post-approval Study

The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the
requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100
subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years
to assess the long-term safety of the leads.

Inclusion Criteria:

- Provision of written informed consent and/or authorization for access to and use of
health information by subjects or appropriate legal guardians as required by an
institution's Investigational Review Board, Medical Ethics Board, or Research Ethics
Board

- Availability of implant, follow-up, and product-related event data

- Implanted with a Model 4968 Capsure Epi Lead

Exclusion Criteria:

- Subjects receiving an implant of a Medtronic lead at a non-participating center and
the implant data and current status cannot be confirmed within 30 days after implant

- Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study
center

- Subjects implanted with a Medtronic cardiac therapy device whose predetermined
enrollment limit for that specific product has been exceeded

- Subjects with exclusion criteria required by local law