User's Manual

US-ENGLISH – 17
5.2. 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.
 Table 1: Summary of Symphony safety data during
study
Patients
Number of
events
Number of
patients
% of
patients
Number of
events
Events per
device year
(a)
Deaths
0
0
0
0
Explants
0
0
0
0
Serious
pacemaker
related events
outside the use
of SafeR
0
0
0
0
Non-serious
pacemaker
related events
outside the use
of SafeR
0
0
0
0
Serious events
due to the use
of SafeR
0
0
0
0