Medtronic Adapta/Versa/Sensia Long Term Reliability Study
Medtronic Adapta/Versa/Sensia Long Term Reliability Study
The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).
The rate of device malfunctions will be determined and a comparison to historical controls will be done.
Inclusion Criteria:
AND one of the following must also apply:
Exclusion Criteria:
Homburg/Saar, Germany