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3.0 INDICATIONS OF USE
The OPTIMIZER INTEGRA CCM-D System is indicated for the prevention
of sudden cardiac death, improvement of quality of life, and 6-minute walk
in Stage C or D heart failure patients who remain symptomatic despite
being on guideline-directed medical therapy (GDMT), are not indicated for
Cardiac Resynchronization Therapy (CRT), and have heart failure with
reduced left ventricular ejection fraction (LVEF ≤ 40%).
The OPTIMIZER Integra CCM-D system delivers non-excitatory CCM
signals to the heart and performs ICD and short-term pacemaker
functions.
4.0 POTENTIAL COMPLICATIONS
4.1 Complications Associated with Implantation
As with any surgical procedure, the implantation of the
OPTIMIZER Integra CCM-D 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 Integra CCM-D 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 (more frequently than 5%)
• Post-procedural pain, bruising, and discomfort at insertion site
• Bleeding
• Infection at site of insertion
• Pocket hematoma
• Movement of leads
• Movement of IPG in the pocket
Uncommon (less frequently than 5%) but serious
• Chest trauma (such as a collapsed lung or bleeding into the
chest)
• Inappropriate detection of arrhythmia resulting in an
unnecessary ICD shock delivered
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