Indications Of Use; Potential Complications; Complications Associated With Implantation - Impulse Dynamics OPTIMIZER Lite System Patient Manual

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INDICATIONS OF USE

The OPTIMIZER Lite System, which delivers CCM™ therapy, is indicated
to improve 6-minute hall walk, quality of life, and functional status of NYHA
Class III heart failure patients who remain symptomatic despite guideline
directed medical therapy, are not indicated for Cardiac Resynchronization
Therapy (CRT), and have a left ventricular ejection fraction ranging from
25% to 45%.
The OPTIMIZER Lite system delivers non-excitatory CCM pulses to the
heart and has no pacemaker or ICD functions.
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POTENTIAL COMPLICATIONS

4.1
As with any surgical procedure, the implantation of the
OPTIMIZER Lite IPG involves some degree of risk. This section is
intended to provide you with an explanation of the various
potential complications associated with having a device implanted.
These potential complications are not unique to the OPTIMIZER
Lite IPG, as they may also occur during the implantation of other
implantable cardiac devices (e.g., cardiac pacemakers or
defibrillators).
The risks associated with the implantation are listed in Table 1
and are grouped based on their prevalence.
Table 1: Risks Associated with Implantation
Common (greater than or equal to 5%)
•
Post-procedural pain, bruising, and 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 complication
•
Cardiac perforation (puncture of the heart caused by the
leads)
•
Endocarditis (infection of the heart valves)

Complications Associated with Implantation

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