User's Manual

US-ENGLISH – 23
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 STUDY
SafeR mode in PARADYM RF is similar to that in Symphony.
The differences in SafeR mode between the two devices are:
 To prevent long RR intervals during VT/VF, SafeR 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.
 PARADYM RF 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.