User Manual

18 Lumax Technical Manual
In addition, patients implanted with the ICD/CRT-D system may
have the following risks. These are the same risks related with
implantation of any ICD/CRT-D system:
 Acceleration of
arrhythmias (speeding
up heart rhythm caused
by the CRT-D)
 Dependency
 Depression
 Fear of premature
battery depletion (fear
that battery will stop
working before predicted
time)
 Fear of shocking while
awake
 Fear that shocking
ability may be lost
 Anxiety about the CRT-D
resulting from frequent
shocks
 Imagined shock (phantom
shock)
 Inappropriate detection of
ventricular arrhythmias
 Inappropriate shocks
 Potential death due to
inability to defibrillate or
pace
 Shunting current or
insulating myocardium
during defibrillation with
external or internal paddles
There may be other risks associated with this device that are
currently unforeseeable.
1.5.2 Observed Adverse Events
Reported Adverse Events are classified as either observations or
complications. Complications are defined as clinical events that
require additional invasive intervention to resolve. Observations
are defined as clinical events that do not require additional
invasive intervention to resolve.
1.5.2.1 Kronos LV-T Study
NOTE:
The Kronos LV-T CRT-D is an earlier generation of
BIOTRONIK devices. The Lumax CRT-Ds are based upon
the Kronos LV-T and other BIOTRONIK CRT-Ds and ICDs
(i.e., Tupos LV/ATx CRT-D, Lexos and Lumos families of
ICDs).