16 Stratos
1.6Potential Effects of the Device on
Health
The following possible adverse events may occur with this type of
| Potential Adverse Events | ||
• | Air embolism | • | |
• | Allergic reactions to |
| thrombosis |
| contrast media | • Local tissue reaction / | |
• | Arrhythmias | • | fibrotic tissue formation |
• | Bleeding | Muscle or nerve | |
• | Body rejection | • | stimulation |
| phenomena | Myocardial damage | |
• | Cardiac tamponade | • | Myopotential sensing |
• | Chronic nerve damage | • | Pacemaker mediated |
• Damage to heart valves | • | tachycardia | |
• | Elevated pacing | Pneumothorax | |
| thresholds | • | Pocket erosion |
• | Extrusion | • | Hematoma |
• | Fluid accumulation | • | Device migration |
• | Infection | • | Thromboembolism |
• | Keloid formation | • | Undersensing of |
• | Lead dislodgment | • | intrinsic signals |
• Lead fracture / insulation | Venous occlusion | ||
| damage | • | Venous or cardiac |
perforation