User's Manual

6 – US-ENGLISH
3. CONTRAINDICATIONS
Implantation of PARADYM RF SonR CRT-D 9770 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.
4. WARNINGS AND PRECAUTIONS
The patient should be warned of the potential risks of defibrillator
malfunction if he is exposed to external magnetic, electrical, or
electromagnetic signals.
These potential interference sources may cause conversion to
inhibited mode (because of noise detection), erratic delivery of VT or
VF therapies, nominal programming, or much more rarely,
irreversible damage to the device’s circuits.
The main sources of high magnitude electrical interference are:
powerful radiofrequency equipment (radar), industrial motors and
transformers, induction furnaces, resistance and arc-welding
equipment, and high power loudspeakers.
Be aware that the changes in the patient’s condition, drug regimen,
and other factors may change the defibrillation threshold (DFT) which
may result in non-conversion of the arrhythmia post-operatively.
Successful conversion of ventricular fibrillation or ventricular
tachycardia during arrhythmia conversion testing is no assurance
that conversion will occur post-operatively.