Not Related: An event for which an alternative explanation is conclusively identified–e.g., concomitant drug(s), concomitant disease(s), and/or the relationship in time suggests that a causal relationship is highly unlikely.
Related: The adverse event follows a reasonable temporal sequence related to treatment by the device, follows a known or suspected response pattern and a plausible alternative etiology cannot be identified.
Undetermined: The relation of the adverse event has some temporal relationship to the device and/or device procedure, is not clearly due to another condition and the involvement of the study device is unknown.
