Impulse Dynamics OPTIMIZER Lite System Patient Manual page 11

•
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
•
Vessel trauma (perforation, dissection, or rupture)
•
Thrombosis (formation of blood clots in the veins)
•
Damage to the specific type of heart tissue responsible for
triggering heartbeats (i.e., the cardiac conduction system)
•
Allergic reaction
Rare (less than 1%)
•
Bradycardia (slow heart rate)
•
Cardiac tamponade (buildup of fluid around the heart that can
be life-threatening)
•
Myocardial infarction (heart attack)
•
Mini stroke (TIA), or stroke
•
Death
In addition, if you have a thin heart wall, you may experience a
hiccup each time the device delivers a CCM signal due to the
stimulation of the phrenic nerve or of the diaphragm itself. This
may require surgical correction.
You may also be sensitive to one or more of the materials used in
your OPTIMIZER Lite IPG that are exposed to the tissues of the
body (histotoxic reaction). Though rare, this may require the
removal of the device. The materials that are in Contact with
Human Tissue are Titanium, Epoxy resin, and Silicone rubber.
The OPTIMIZER Lite IPG uses its leads to detect the electrical
activity of your heart. 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