BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 31 / 176

Lumax Technical Manual 23
For the Tupos LV/ATx study group, there were 210 observations
in 104 patients with cumulative implant duration of 1240.4 months
(101.9 patient years). 78.2% of the enrolled study patients have a
reported observation. The rate of observations per patient-year
was 2.06.
Table 4 summarizes by category each type of
observation for the study group.
Table 4: Summary of Observations – Tupos LV/ATx
Category
Number
of
Patients
% of
Patients
Number
per patient-
year
Procedure Related
Hematoma 10 7.52% 10 0.10
Cardiac arrest 2 1.50% 2 0.02
Unable to implant
system
1 0.75% 1 0.01
Total 13 9.77% 13 0.13
Atrial Lead Related
Dislodgement 1 0.75% 1 0.01
High threshold 1 0.75% 1 0.01
Total 2 1.50% 2 0.02
ICD Lead Related
High threshold/No
capture
1 0.75% 1 0.01
Total 1 0.75% 1 0.01
LV Lead Related
High threshold/
Intermittent
biventricular capture/
No capture
24 18.05% 24 0.24
Diaphragmatic/
Intercostal stimulation
8 6.02% 8 0.08
Total 30 22.56% 32 0.31