User's Manual

6 – US-ENGLISH
1. GENERAL DESCRIPTION
PARADYM RF DR 9550 is an implantable dual-chamber cardioverter
defibrillator. It is equipped with an accelerometer to allow adaptation
of pacing to suit the patient’s activity.
2. INDICATIONS
This device is indicated for use in patients who are at high risk of
sudden cardiac death due to ventricular tachyarrhythmias and who
have experienced one of the following situations:
 Survival of at least one episode of cardiac arrest (manifested by
the loss of consciousness) due to ventricular tachyarrhythmia,
 Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
NOTE: The clinical outcome for hemodynamically stable VT
patients is not fully known. Safety and effectiveness studies have
not been conducted.
3. CONTRAINDICATIONS
Implantation of PARADYM RF DR 9550 is contraindicated in
patients:
 whose ventricular tachyarrhythmias may have transient or
reversible causes such as: acute myocardial infarction, digitalis
intoxication, drowning, electrocution, electrolyte imbalance,
hypoxia, sepsis, or unstable ischemic episodes,
 who present incessant tachyarrhythmia,
 who have an internal pacemaker,
 whose primary disorder is bradyarrhythmias, or atrial
tachyarrhythmias.
Dual-chamber and single chamber atrial pacing is contraindicated in
patients with chronic refractory atrial tachyarrhythmias.