User Manual

Table Of Contents

Lumax Technical Manual 17

1.5 Potential/Observed Effects of the

Device on Health

1.5.1 Potential Adverse Events

The following are possible adverse events that may occur relative

to the implant procedure and chronic implant of the CRT-D:

 Air embolism

 Allergic reactions to

contrast media

 Arrhythmias

 Bleeding

 Body rejection

phenomena

 Cardiac tamponade

 Chronic nerve damage

 Damage to heart valves

 Device migration

 Elevated pacing

thresholds

 Extrusion

 Fluid accumulation

 Hematoma

 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

 Thromboembolism

 Under sensing of intrinsic

signals

 Venous occlusion

 Venous or cardiac

perforation