Impulse Dymanics OPTIMIZER Smart System - Ventricular Arrhythmias Potentially Caused by CCM Signals; Atrial Arrhythmias Potentially Caused by CCM Signals

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fixation and by limiting the number of lead manipulations. Please read and follow
all directions of the original Physician Manual for the leads that you intend to use
to minimize adverse events connected to lead implantation.
4.2.2 Ventricular Arrhythmias Potentially Caused by CCM Signals
CCM signals are of greater strength than that of typical pacing pulses and are thus
capable of eliciting activation of cardiac tissue when delivered outside of the
absolute refractory period. CCM signals delivered outside of the ventricular
absolute refractory period thus have the potential of causing signal-induced
arrhythmias (some of which may be life-threatening, such as ventricular
fibrillation and tachycardia). For this reason, it is imperative that CCM signal
delivery parameters be chosen carefully. Most importantly, the various settings
related to conditions that inhibit CCM signal delivery (e.g. Long AV Delay, Short
AV Delay, LS Alert Window, refractory periods, and IEGM sensitivities) must be
selected to allow delivery of CCM signals only on normally conducted beats, but
inhibit them on beats of suspected ectopic or premature origin.
In addition, CCM signals may cause changes in the electrical conduction of tissue.
For this reason, the delivery of CCM signals to the ventricular septum has the
potential of causing bundle branch block that could lead to bradycardia. Through
similar mechanisms, CCM-induced changes in the electrical conduction of the
myocardium have the potential of inducing tissue refractoriness that may facilitate
the induction of reentrant tachyrrhythmias. It is recommended that the patient’s
rhythm be monitored carefully for changes in rhythm when CCM signals are
delivered during lead implantation, as well as during first activation of the
OPTIMIZER Smart IPG and subsequent follow-up visits. Changes in ventricular
rhythm caused by the delivery of CCM signals may require relocating the leads,
as well as reprogramming the CCM delay and amplitude to settings that do not
cause changes in the patient’s ventricular rhythm.
4.2.3 Atrial Arrhythmias Potentially Caused by CCM Signals
Atrial and supraventricular arrhythmias could theoretically be initiated when
CCM-induced ventricular activity is conducted retrograde to the atria, resulting in
premature atrial depolarization. The OPTIMIZER Smart IPG may sense the
ventricular activation resulting from the retrograde-induced atrial event and
deliver CCM as programmed. In addition, strong CCM signals delivered through
leads implanted in basal position close to the atria have the potential of directly
stimulating the atria. If CCM delivery causes atrial activation through either of
these mechanisms, and the atrial signal is then conducted to the ventricles, the
cycle may develop into a condition similar to pacemaker-mediated tachycardia
(PMT).