User's Manual

6 – US-ENGLISH
1. GENERAL DESCRIPTION
PARADYM RF VR 9250 is an implantable single-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 VR 9250 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.