CARDIOVASCULAR
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SAFETY INFORMATION FOR PA SENSORS, CRT-Ps, CRT-Ds and LVADs

PULMONARY ARTERY (PA) CARDIOMEMS PRESSURE SENSOR IMPORTANT SAFETY INFORMATION
INTERFERENCE

As with any procedure, there are potential risks involved with having a PA sensor implanted, including electromagnetic interference. Your doctor is the best source of information about risks. A small percentage of patients may develop complications from the procedure, including: arrhythmias, bleeding, death, device embolization, hematoma (blood clot), infection, myocardial infarction (heart attack), stroke, transient ischemic attack (often called a ministroke) and thrombus (blood clot).

Your PA sensor has built-in features that protect it from interference produced by most electrical equipment. Most of the things you handle or work around on a daily basis are not going to affect your sensor. Any type of electromagnetic interference such as theft detection systems and airport security systems could make it difficult to take sensor measurements. It would be highly unlikely that you would be taking measurements at the same time that these devices are in your vicinity. Electric blankets or waterbeds could be the possible exception because they are found in the home and could be in the area when measurements are taken. If they are causing interference, you may want to move the electric blanket out of the room or in the case of a waterbed take the measurement in another room.

Consult your doctor about all possible benefits and risks.

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. After receiving a CRT-P, items with strong magnetic fields, including MRI machines, should be avoided. Some appliances and tools also can affect the device.

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) IMPORTANT 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. After receiving a CRT-D, items with strong magnetic fields, including MRI machines, should be avoided.

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) IMPORTANT SAFETY INFORMATION

Complications of surgery to receive an LVAD are similar to the potential complications of any open heart surgery procedure. You will be asked to sign a surgical consent form prior to the operation, as well as a consent form for blood transfusions. Your surgeon will discuss potential risks and benefits with you prior to the procedure.

Possible serious adverse events include death, bleeding (during surgery or after surgery), cardiac arrhythmia (irregular heartbeat), local infection, respiratory failure, device malfunction, sepsis (serious infection), right heart failure, driveline or pocket infection, renal failure (inability of the kidneys to remove waste from the blood), stroke, neurologic dysfunction (problems affecting the brain or nervous system), psychiatric episode, thromboembolic event, peripheral (blood clots), hemolysis (breakdown of red blood cells), hepatic dysfunction (liver problems), device thrombosis (formation of a blood clot inside the device) and myocardial infarction (heart attack).

Individual experiences, symptoms, situations, and circumstances may vary. Please consult your physician or qualified healthcare provider regarding your condition and appropriate medical treatment.

PRODUCT ADVISORIES

Abbott Cardiovascular is committed to presenting information with accuracy and integrity. Occasionally we discover product issues that we feel are important to share with patients. These notices will be published here.

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