5. ADVERSE EVENTS
5. ADVERSE EVENTS
Clinical data presented in this section are from the MSP clinical study.
INTENSIA SonR CRT-D 184 is similar in design and function to the ALTO 2 MSP and
OVATIO CRT-D devices. The data provided are applicable to INTENSIA SonR CRT-D 184.
5.1.
MSP STUDY
Sorin conducted an international, multi-center, randomized clinical trial of its cardiac
resynchronization therapy system. Investigators attempted to implant study devices in 190
patients. A total of 182 patients received study devices and had an exposure of over 165
device years. Of those patients, 19 received OVATIO CRT-D, 160 received ALTO 2 MSP,
and 3 received ALTO MSP. The clinical data collected on ALTO MSP, ALTO 2 MSP and
OVATIO CRT-D are applicable to INTENSIA SonR CRT-D 184. The table below summarizes
the adverse events observed for the CRT-D system. No deaths were related to the system.
Event
# of Patients
% of Patients
# of Events
Events/100
Device-Years
Deaths not related to the
system
16
8.4
16
0.8
Cardiac arrest
5
2.6
5
0.3
Worsening CHF / CHF
decompensation
3
1.6
3
0.2
Multi-organ dysfunction
2
1.1
2
0.1
Complications related to the
system
28
14.7
35
2.1
Dislodgment or migration
9
4.7
11
0.6
Extracardiac stimulation (e.g.,
phrenic stim)
9
4.7
9
0.5
Complications related to the
implant procedure
18
9.5
21
1.3
Dislodgment or migration
4
2.1
4
0.2
Observations related to the
system
23
12.1
27
1.7
Extracardiac stimulation (e.g.,
phrenic stim)
12
7.9
15
0.8
Observations related to the
implant procedure
24
12.6
28
1.7
Heart block
6
3.2
6
0.3
Extracardiac stimulation (e.g.,
phrenic stim)
3
1.5
5
0.3
SORIN – INTENSIA SonR CRT-D 184 – U150A
13
Содержание Intensia SonR CRT-D 184
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