Table 2 Summary of adverse events
Adverse events | Non-device-related | Device-related | |
|---|---|---|---|
Non-serious | Adverse event (AE) | Adverse device effect (ADE) | |
Serious | Serious adverse device effect (SADE) | ||
Anticipated | Unanticipated | ||
Anticipated serious adverse device effect (ASADE) | Unanticipated serious adverse effect (USADE) | ||