User's Manual

18 – US-ENGLISH
Patients
Number of
events
Number of
patients
% of
patients
Number of
events
Events per
device year
(a)
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
Non-serious events due to the use of SafeR included: delay in
switching on 2nd degree AV block, inappropriate classification of a
PAC, disagreement between markers and recorded EGM, atrial
pacing above the maximum rate, recycling on an r-wave in a
refractory period, and disagreement in the statistics for switches to
DDD. No patient symptoms were associated with these events.