Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

Anyone who has received a Medtronic heart device that helps with their heart rhythm (like a pacemaker or defibrillator) is potentially able to join this study. You will need to agree, in writing, for researchers to use your health information for the study. This is a very important step to make sure your privacy is protected.

Also, if you're about to get one of these devices, or had one implanted in the last 30 days, you could be included. Even if you were part of an earlier study (called an IDE study) for a Medtronic device and have complete records, you might be eligible if you agree to share that past information.

However, you might not be able to join if you can't be reached for follow-up appointments, or if your local laws prevent it. Also, if your device was put in at a hospital that isn't part of this study and your implant information can't be confirmed quickly, or if too many people with your specific device type have already joined, you wouldn't be able to take part.

If you are part of this study, it mainly involves allowing researchers to gather information about your Medtronic heart device. They're interested in how it performs over time. This typically means they will look at your existing medical records related to your device without you needing to do anything extra. You won't have to take a new medication, attend extra clinic visits beyond your usual check-ups, or have any special assessments just for this study. The study continues for as long as needed to track the long-term performance of these devices, but your individual participation is passive, meaning you don't take an active role other than giving your permission for data use.