User's Manual

US-ENGLISH – 59
18. SUPPLEMENTAL INFORMATION
Clinical data presented in this section are from the SafeR clinical study.
SafeR operation in PARADYM RF is similar to that in the Symphony
pacemaker. The data provided are applicable to PARADYM RF CRT-
D.
18.1. ADVERSE EVENTS IN THE SAFER STUDY
Clinical study of the SafeR included 45 Symphony 2550 devices
implanted in 45 patients. No serious adverse events were device- or
feature-related. There were no deaths in the study. Table 1
summarizes the safety data for this study.