What To Do If Your Medical Device Is Recalled

Advice on what to do

When someone has an implanted device such as a pacemaker or implantable defibrillator (ICD), they depend on that device to treat their irregular heart rhythm. To function properly, there is the device itself (the pacemaker or ICD) and the leads or wires that go from the device to your heart.

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Pacemakers, ICDs and leads go through careful product safety standards to make sure they are safe and reliable. After they are in market, the device company must track the devices and report any malfunction. There are times, when you may read about a pacemaker or ICD device or the leads in the news. This can be scary and cause you to worry. Here are some tips to follow if you hear about a medical device in the news:

1. Don’t panic.

Even if your device or lead is on a list of concern, failure is fairly rare. Your leads will probably continue to function well.

2. Contact your doctor.

Your doctor can tell you if your device is on the list of devices or leads of concern.

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3. Choose the right medical center.

Lead replacement is possible, however not performed routinely. If this is necessary, you should go to a center with experience in this technique. Replacement surgery has risks and benefits. Your doctor will help you make the best decision based on your risk of device failure compared to the risk of surgery.

4. Keep up with checkups.

Stick to your regularly scheduled visits and device checks to make sure your device is functioning properly. Your doctor may want to monitor you more regularly.

5. Be mindful of changes.

If you notice any signs of shocks, alarms, or symptoms of abnormal beats such as palpitations, dizziness, or extreme fatigue contact your doctor.

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Bruce Lindsay, MD, Section Head of Electrophysiology and Pacing states, “When device recalls are issued by the FDA, we evaluate them carefully and contact each patient with specific recommendations for appropriate follow up.”

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