Impulse Dynamics OPTIMIZER Integra CCM-D Patient Manual page 11

•
Failure to detect an arrhythmia and failure to deliver a life-
saving shock when needed
•
Puncture of the heart caused by the leads
•
Endocarditis (infection of the heart valves)
•
Arrhythmia (irregular heartbeat, including heartbeats that are
too slow or too fast)
•
Tricuspid valve damage (the valve between the right upper
and lower chambers of the heart that prevents blood from
flowing back into the upper chamber), possibly leading to
tricuspid valve regurgitation or leakage
•
Thrombosis (formation of blood clots in the veins)
•
Vessel trauma (puncture or tear of a blood vessel)
•
Damage to the specific type of heart tissue responsible for
triggering heartbeats (i.e., the cardiac conduction system)
•
Bradycardia (slow heart rate)
•
Cardiac tamponade (build up of fluid around the heart that can
be life-threatening)
•
Myocardial infarction (heart attack)
•
Mini stroke (TIA), or stroke
•
Death (in rare cases)
Rare (less frequently than 1%)
•
Allergic reaction (allergic reaction to the dye used during the
implant procedure)
•
Death (in rare cases)
The OPTIMIZER Integra CCM-D IPG uses its leads to detect the
electrical activity of your heart as well as deliver CCM therapy,
shocks, and short-term emergency pacing. Complications that can
affect the lead's ability to perform this function may occur. These
include:
•
A lead may become dislodged from where it was placed
during implantation, necessitating re-operation.
•
A lead may fracture or break producing a poor electrical
connection, necessitating re-operation.
The lead problems described above can occur at any time during
the implant life of a lead. Surgical correction is typically required.
5