Table 7.

Adverse event definitions: relationship to procedure

Relationship	Description
Not related	Any reaction that does not follow a reasonable temporal sequence from administration of the study device AND that is likely to have been produced by the subject’s clinical state or other modes of therapy administered to the subject
Unlikely	Any reaction that does not follow a reasonable temporal sequence from administration of the study device or that is likely to have been produced by the subject’s clinical state or other modes of therapy administered to the subject
Likely	A reaction that follows a reasonable temporal sequence from administration of the study device OR that follows a known response pattern to the suspended device AND that could not be reasonably explained by the known characteristics of the subject’s clinical state or other modes of therapy administered to the subject
Definite	A reaction that follows a reasonable temporal sequence from administration of the study device AND that follows a known response pattern to the suspected device AND that recurs with rechallenge, and/or is improved by removing the device