User Manual

18. SUPPLEMENTAL INFORMATION
18. SUPPLEMENTAL INFORMATION
Clinical data presented in this section are from the SafeR (AAI <> DDD) clinical study. SafeR
(AAI <> DDD) operation in INTENSIA is similar to that in the Symphony pacemaker. The
data provided are applicable to INTENSIA SonR CRT-D 184.
18.1. ADVERSE EVENTS IN THE SAFER (AAI <> DDD) STUDY
Clinical study of the SafeR (AAI <> DDD) 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: 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 (AAI <>
DDD)
0 0 0 0
Non-serious
pacemaker
related events
outside the use of
SafeR (AAI <>
DDD)
0 0 0 0
Serious events
due to the use of
SafeR (AAI <>
DDD)
0 0 0 0
Non-serious
events related
due to the use
SafeR (AAI <>
DDD)
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 2 (AAI <> DDD) 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
46
SORIN – INTENSIA SonR CRT-D 184 – U150A