Medtronic CRDM Product Performance Report
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.
⁃ • Subject or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information as required by an institution's IRB/MEC/REB
⁃ AND one of the following must also apply:
• Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
• Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data