User Manual

6. CLINICAL STUDIES
Event Europe (N=38) Number of events* Number of patients Percent of patients
Intent to treat but did
not
0 0 0.0
Non-device related
death
1 1 2.6
Explant 1 1 2.6
Complication 3 2 5.3
Observation 18 14 36.8
Serious non-related
other than death
12 7 18.4
Event All (N=60) Number of events* Number of patients Percent of patients
Intent to treat but did
not
0 0 0.0
Non-device related
death
1 1 1.7
Explant 1 1 1.7
Complication 3 2 3.3
Observation 18 14 23.3
Serious non-related
other than death
13 8 13.3
* A patient can have more than one complication, observation, or serious adverse event, not
device-related.
Device Failures and Replacements:
No device failures or replacements occurred with Defender IV DR 612 during the study.
6.2. SAFER (AAI <> DDD) STUDY
SafeR (AAI <> DDD) mode in INTENSIA is similar to that in Symphony.
The differences in SafeR (AAI <> DDD) mode between the two devices are:
─ To prevent long RR intervals during VT/VF, SafeR (AAI <> DDD) has no effect during
VT/VF therapy, electrophysiologic studies, and post-shock recovery.
─ The maximum acceptable AV delay for first degree AV block varies as a function of
pacing rate.
─ INTENSIA requires a ventricular sensed event to atrial paced event (RA) interval of at
least 100 ms. Therefore, the device lengthens the atrial escape interval so that it ends at
least 102 ms after the ventricular event.
─ During atrial fibrillation episode, pause criterion is fixed to 2s to avoid long bradycardia
episodes in switching to DDD mode.
Despite these differences, the data collected on Symphony devices are applicable to
INTENSIA because the principles of SafeR (AAI <> DDD) operation did not change. The
18
SORIN – INTENSIA DR 154 – U152A