User's Manual

18 – US-ENGLISH
5.2. POTENTIAL ADVERSE EVENTS
Adverse events (in alphabetical order), including those reported in the
previous tables, associated with ICD systems include:
─ Acceleration of arrhythmias (caused by device),
─ Air embolism,
─ Bleeding,
─ Chronic nerve damage,
─ Erosion,
─ Excessive fibrotic tissue growth,
─ Extrusion,
─ Fluid accumulation,
─ Formation of hematomas or cysts,
─ Inappropriate shocks,
─ Infection,
─ Keloid formation,
─ Lead abrasion or fracture,
─ Lead migration/dislodgment,
─ Myocardial damage,
─ Pneumothorax,
─ Shunting current or insulating myocardium during defibrillation with
internal or external paddles,
─ Potential mortality due to inability to defibrillate or pace,
─ Thromboemboli,
─ Venous occlusion,
─ Venous or cardiac perforation.