User's Manual

22 – US-ENGLISH
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.