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