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Pacemaker Safety, ICD Safety and Ablation Safety Information

Pacemaker: Important safety information

An implantable pacemaker monitors the heart’s rhythm and provides electrical stimulation when the heart does not beat or beats too slowly. The pacemaker is designed for patients who have an abnormally slow heart rate.

Your doctor is the best source of information about the risks of having a pacemaker. Be sure to talk with your doctor about all of your questions and concerns. The following is a summary of risk information. For a complete list, please see the link to the patient manual at the bottom of this section.

Implanting a pacemaker is considered minor surgery, but a small number of patients will develop complications because of the implant procedure. They may include infection, a reaction to a drug used during surgery or to the device itself and blood loss or damage to a blood vessel, the heart wall or other organs. These complications can usually be corrected or cured, but may require a repeat operation or a longer than normal hospital stay. After the surgery, you will feel some discomfort, and you will be tired. As you recover, you will feel better. However, some patients continue to feel some discomfort where the pacemaker is implanted. Speak to your doctor if this occurs.

It is important to follow certain precautions after you get a pacemaker. You can use most household appliances safely, if in good repair and properly grounded, but you should avoid items with strong magnetic fields.

Although most medical equipment will have no effect on your device, some may affect its function. Tell the hospital personnel that you have a device before you undergo any medical procedure, such as electrosurgery, electrocautery, lithotripsy or radiation therapy, or a dental procedure or test. Do not undergo any diathermy procedure, even if your device has been turned off. It could cause damage to the tissue around the implanted electrodes or permanent damage to the device. Try to avoid electrical nerve and muscle stimulators (TENS units). They may interfere with the function of your device. Magnetic resonance imaging (MRI) scans can severely damage your device. When you are in or near an MRI room, your device might be affected.

Your doctor will discuss with you all the precautions you should follow. Also, read completely any literature that came with your device, and pay close attention to sentences that are labeled with the word “warning” or “important.” Those sentences contain important safety information. Finally, remember these are man-made devices. It is important to monitor the device regularly with follow-up visits as often as your doctor recommends.

Our guides and brochures also contain important safety information.

Implantable cardioverter defibrillator (ICD): Important safety information

An implantable cardioverter defibrillator (ICD) treats dangerously fast rhythm disorders called ventricular tachycardia and ventricular fibrillation in the lower chambers of the heart. The ICD sends a shock to the heart muscle to interrupt the rhythm disorder and allow the heart to resume its normal rhythm.

Your doctor is the best source of information about the risks of having an ICD. Be sure to talk with your doctor about all your questions and concerns. The following is a summary of risk information. For a complete list, please see the link to the patient manual at the bottom of this section.

A small percentage of ICD patients will develop complications because of the implant surgery. They may include infection, a reaction to a drug used during surgery or to the device itself and blood loss or damage to a blood vessel, the heart wall or other organs. After the surgery, you will feel some discomfort, and you will be tired. As you recover, you will feel better. However, some patients continue to feel some discomfort where the ICD is implanted. Speak to your doctor if this occurs.

It is important to follow certain precautions after you get an ICD. You can use most household appliances safely, if in good repair and properly grounded, but you should avoid items with strong magnetic fields. Although most medical equipment will have no effect on your device, some may affect its function. Tell the hospital personnel that you have a device before you undergo any medical procedure, such as electrosurgery, electrocautery, lithotripsy or radiation therapy, or a dental procedure or test. Do not undergo any diathermy procedure, even if your device has been turned off. It could cause damage to the tissue around the implanted electrodes or permanent damage to the device. Try to avoid electrical nerve and muscle stimulators (TENS units). They may interfere with the function of your device. Magnetic resonance imaging (MRI) scans can severely damage your device. When you are in or near an MRI room, your device might be affected.

Your doctor will discuss with you all the precautions you should follow. Also, read completely any literature that came with your device, and pay close attention to sentences that are labeled with the word “warning” or “important.” Those sentences contain important safety information.

When an arrhythmia occurs, ICD treatment may not end it, or treatment may make the arrhythmia worse. In either case, the ICD then delivers stronger treatment to try to end the arrhythmia. There is a slight risk that the ICD may fail to deliver treatment when you need it, or it may deliver treatment when you do not need it. The ICD may not always eliminate all symptoms of the arrhythmia. You still may feel lightheaded or dizzy, or you may faint.

Our guides and brochures also contain important safety information.

Ablation: Important safety information

Catheter ablation uses high frequency electrical energy or other energy to correct fast heartbeats by scarring or destroying tissue that affects the electrical signals that travel through the heart. Your doctor is the best source of information about the risks of having a catheter ablation procedure. Be sure to talk about all of your questions and concerns. The following is a summary of risk information. Procedure risks may include esophageal perforation, coronary artery injuries, phrenic nerve paralysis, infection, damage to the heart or blood vessels and blood clots. Bleeding, swelling or bruising may occur at the catheter insertion sites.

It is also possible that the heart’s normal electrical system could be damaged during this procedure. Generally, risks depend on age, general health, specific medical conditions and heart function. If this occurs, an artificial pacemaker may be necessary. Following the procedure, you will be moved to a recovery area where you will be monitored for complications from the procedure. Although all types of anesthesia involve some risk, individual side effects and complications from anesthesia can vary. Specific risks can differ depending on various health factors. Any potential concerns should be discussed with your physician. Catheter ablation is often successful; however some people require repeat procedures. You may also need to take medication, even after you have had an ablation procedure. Your doctor will determine the best option for you. This procedure is available by prescription only and is not right for everyone. Individual results may vary.

Our guides and brochures also contain important safety information.

Arrhythmia product, ICD and pacemaker advisories

St. Jude Medical is committed to presenting information with accuracy and integrity. Occasionally we discover product issues that we feel are important to share with patients. We will publish these notices here.