User's Manual
16 – US-ENGLISH
5.3. 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
Pocket hematoma
2
5.3
2°
10.5
Pocket
infection/hematoma
1
2.6
1°
5.2
Pocket infection
from previous
pacemaker
1
2.6
1°
5.2
Prolonged implant
procedure
1
2.6
1
5.2
Sensor acceleration
during telemetry***
1
2.6
1
5.2
Shock for VT in VF
Zone
1
2.6
1°
5.2