BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 30 / 176

22 Lumax Technical Manual
Table 3: Summary of Complications – Tupos LV/ATx
Category
Number
of
Patients
% of
Patients
Number of
Complications
Complications
per patient-
year
Device Related
Infection 3 2.26% 7 0.07
Device migration 4 3.01% 4 0.04
Elective replacement
indicator reached
4 3.01% 4 0.04
Inductions and
conversions
1 0.75% 1 0.01
Unable to interrogate
device
1 0.75% 1 0.01
Total 12 9.02% 17 0.17
Total Procedure
and Device Related
43 32.33% 58 0.57
Other Medical Related
Non-CHF Cardiac
Symptoms
4 3.01% 4 0.04
Ventricular
arrhythmias
2 1.50% 3 0.03
Other medical 2 1.50% 2 0.02
Atrial arrhythmia 1 0.75% 1 0.01
Total 9 6.77% 10 0.10
Total – All Patients
and Categories
50 37.59% 68 0.67
Number of Patients = 133, Number of Patient-Years = 101.9
* 1 Unanticipated Adverse Device Effect (UADE) occurred with a
Tupos LV/ATx CRT-D during the OPTION clinical study. The device was
explanted after it was unable to be interrogated with the programmer
software and no pacing output was evident. The analysis showed an
appropriately depleted battery and no anomalies with the IC module. The
battery depletion strongly suggests that the high voltage circuit was
activated over a prolonged period due to a single-bit execution path
failure. The current programmer software with Automatic Battery
Management (ABM) would have prevented the battery from becoming
completely depleted. There were no other instances of this failure
mechanism in Tupos LV/ATx devices.