User's Manual

US-ENGLISH – 61
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
Non-serious events
related due to the use
SafeR
13
28.9
15
3.2
Serious non-
pacemaker related
events
6
13.3
9
1.9
Non-serious non-
pacemaker related
events
8
17.8
8
1.7
(a) 4.74 device years