Impulse Dynamics AIM HIGHer OPTIMIZER, Patient Manual

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4
Table 1: Risks Associated with Implantation
Common (greater than or equal to 5%)
•
Post-
procedural pain, b
ruising, a
nd discomfort at insertion site
• Bleeding
•
Infection at site of insertion
•
Pocket hematoma
• Migration of leads
•
Migration of
implanted IPG
Uncommon (between 1-5%)
•
Chest trauma (such as a
collapsed
lung or
bleeding
into the
chest
)
•
Generator complicat
ion
• Cardiac perforatio
n (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
• Vessel trauma (perforation, dissection, or rupture)
•
Thrombosis
(formation of
blood
clots in the vein
s)
•
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 (build
up of
fluid around
the heart that can
be
life-
threatening)
• Myocardial infarction
(heart
attack)
•
Mini stroke
(TIA),
or stroke
•
Death