BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 29 / 176

Lumax Technical Manual 21
Complications and observations for the Tupos LV/ATx study
group are summarized in
Table 3 and Table 4 . The total number
of patients may not equal the sum of the number of patients listed
in each category, as an individual patient may have experienced
more than one complication or observation.
Table 3: Summary of Complications – Tupos LV/ATx
Category
Number
of
Patients
% of
Patients
Number of
Complications
Complications
per patient-
year
Procedure Related
Hematoma 4 3.01% 4 0.04
Pneumothorax 2 1.50% 2 0.02
Total 6 4.51% 6 0.06
Atrial Lead Related
Dislodgement 3 2.26% 3 0.03
Total 3 2.26% 3 0.03
ICD Lead Related
High threshold/ No
capture
2 1.50% 2 0.02
Diaphragmatic/
Intercostal
stimulation (RV)
1 0.75% 1 0.01
Total 3 2.26% 3 0.03
LV Lead Related
High threshold/
Intermittent
biventricular capture/
No capture
11 8.27% 12 0.12
Unable to implant
lead via coronary
sinus
11 8.27% 11 0.11
Dislodgement 4 3.01% 4 0.04
Diaphragmatic/
Intercostal
stimulation
1 0.75% 2 0.02
Total 27 20.3% 29 0.28