Heart Failure Device and CRT-P Safety and Use | Abbott Cardiovascular
CARDIOVASCULAR
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SAFETY INFORMATION FOR CRT-Ps, CRT-Ds and LVADs

CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) IMPORTANT SAFETY INFORMATION

A CRT-P monitors the heart’s rate and rhythm and provides electrical stimulation when the heart does not beat or beats too slowly. The CRT-P is designed for patients who have an abnormally slow heart rate, and for heart failure patients and patients whose hearts are in need of resynchronization.

As with any surgery, there are potential risks involved with having a CRT-P implanted. Your doctor is the best source of information about risks. A small percentage of patients may develop complications from the implant surgery, including bleeding, infection or lead dislodgement. Lead or device problems also can occur following surgery. Generally, risks depend on age, general health, your specific medical condition and heart function.

This device is available by prescription only and is not right for everyone. Individual results may vary. Consult your doctor about all possible benefits and risks.

CARDIAC RESYNCHRONIZATION THERAPY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (CRT-D) GENERAL SAFETY INFORMATION

CRT-Ds treat dangerously fast rhythm disorders called ventricular tachycardia and ventricular fibrillation in the lower chambers of the heart, and are for heart failure patients and patients whose hearts are in need of resynchronization. For a HF patient or patient whose heart requires resynchronization, the CRT-D sends a shock to the heart muscle to interrupt the rhythm disorder and allow the heart to resume its normal rhythm.

As with any surgery, there are potential risks involved with having a CRT-D implanted. Your doctor is the best source of information about risks. A small percentage of patients may develop complications from the implant surgery, including bleeding, infection or lead dislodgement. Lead or device problems also can occur following surgery. Generally, risks depend on age, general health, your specific medical condition and heart function.

This device is available by prescription only and is not right for everyone. Individual results may vary. Consult your doctor about all possible benefits and risks.

LEFT VENTRICULAR ASSIST DEVICE (LVAD) GENERAL SAFETY INFORMATION

LVADs should not be used in patients who cannot tolerate or are allergic to anticoagulation therapy. Side effects of LVAD therapy may include death, bleeding, cardiac arrhythmia, infection, respiratory failure, device malfunction, sepsis, right heart failure, renal failure, stroke, neurologic dysfunction, psychiatric episode, peripheral or device-related thromboembolic event, haemolysis, hepatic dysfunction and myocardial infarction. Individual experiences, symptoms, situations and circumstances may vary. Consult your physician or qualified health provider regarding your condition and appropriate medical treatment.

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