User's Manual

US-ENGLISH – 15
complications, including device failures and replacements. Fourteen
of the 38 Defender IV DR 612 patients experienced a total of 18
observations. Complications and observations are reported in Tables
1 and 2. It should be noted that a patient can have more than one
observation or complication. There were no observations or
complications in the U.S.
 Table 1: Summary of European Clinical Complications
(Including Device Failures and Replacements)
All complications, 2 of 38 Defender IV DR 612 patients in Europe
Event
# of
Patients
% of
Patients
# of
Events
Events/100
Device-
Years*
Hematoma
1
2.6
1
5.2
Ventricular lead
migration/dislodgment
2
5.3
2
10.5
* There were 228.7 device months in this study.
 Table 2: Summary of European Clinical Complications
(Including Patient Complaints)
All complications, 14 of 38 Defender IV DR 612 patients in Europe
Event
# of
Patients*
% of
Patients
# of
Events
Events/100
Device-
Years**
Change in
ventricular sensing
threshold
1
2.6
1°
5.2
Device reset***
1
2.6
1°
5.2
Inappropriate
therapy for EMI
1
2.6
1°
5.2
Pneumothorax
1
2.6
1°
5.2