Use Instructions

• Lead fracture

• Lead displacement

• Atrial or ventricular perforation

• Rare cases of pericardial tamponade

Perforation of the ventricular wall can induce direct stimulation of the phrenic nerve or the

diaphragm. An impedance change demonstrated on a check-up can be indicative of lead fracture,

lead displacement, lead insulation damage, or perforation (also see: Potential Adverse Effects,

Section 7).

In very rare cases (<1%), transvenous lead placement can lead to venous thrombosis and

subsequent SVC syndrome.

Loss of sensing shortly after implant can be the result of lead displacement. In addition, loss of

CCM therapy delivery could be due to a lead fracture.

5.1.1 Atrial and Ventricular Arrhythmias Potentially Caused by Lead Implantation

The use of transvenous leads may lead to arrhythmias, some of which may be life-

threatening, such as ventricular fibrillation and ventricular tachycardia. The use of screw-

in leads, such as those used for CCM therapy delivery, has the potential of causing

conduction disturbances such as bundle branch block. These can be minimized by

performing the implant under fluoroscopic guidance, ensuring that the leads are placed in

the appropriate position prior to fixation, as well as limiting the number of lead

manipulations.

Please read and follow all directions in the Instruction for Use document provided with the

leads that you intend to use in order to minimize adverse events associated with lead

implantation.

5.1.2 Ventricular Arrhythmias Potentially Caused by CCM therapy pulses

CCM therapy pulses 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 therapy pulses delivered outside of the ventricular

absolute refractory period thus have the potential of causing pulse-induced arrhythmias

(some of which may be life-threatening, such as ventricular fibrillation and tachycardia).

For this reason, it is imperative that CCM therapy delivery parameters be chosen

carefully. Most importantly, the various settings related to conditions that inhibit CCM

therapy 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 therapy only

on normally conducted (e.g., non-arrhythmic) beats, but inhibit them on beats of

suspected ectopic or premature origin.

In addition, CCM therapy pulses may cause changes in the electrical conduction of

tissue. For this reason, the delivery of CCM therapy pulses 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 tachyarrhythmias. It is recommended that the patient be monitored

carefully for changes in heart rhythm when CCM therapy is temporarily activated during

lead implantation, as well as during the first permanent activation of CCM therapy after

implant and subsequent follow-up visits. Changes in ventricular rhythm caused by the

delivery of CCM therapy pulses may require repositioning the leads, and/or changing the

CCM train delay and CCM amplitude parameters to values that do not adversely affect

the patient’s ventricular rhythm.