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Pacemaker Battery Failure Drug Lawsuit SourcePacemaker Lawsuits: Complication Lawsuits

Commonly asked questions about pacemakers:

Recently, there have been increasing concerns about pacemaker devices. Some of these devices have caused serious harm and injury to people due to battery failures. If you have received a pacemaker and experienced complications, you may have a case against the device manufacturer.

What are Pacemakers?

Pacemakers, also known as implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators, are small cardiac devices placed in the chest or abdomen that use electrical impulses to regulate the beating of the heart.

Patients may require pacemakers for a variety of reasons, but generally it is due to arrhythmia, a group of conditions in which the heart’s rhythm is abnormal.

The heart’s rhythm can become abnormal due to natural aging, or as a result of heart muscle damage from a heart attack or heart failure. Other causes of heart rate disruption are medications or genetic conditions.

Pacemakers are implanted in the chest via minor surgery. They can be implanted temporarily or permanently.

The devices work by monitoring your heartbeat, and if it is too slow, the pacemaker will send electrical signals to your heart to speed it up. Most pacemakers can even detect body motion or breathing rate, which can signal the device to increase heart rate during exercise.

What are the Types of Pacemakers?

There are three types of pacemaker devices, depending on the patient’s needs:

  • Single chamber pacemaker – Carries electrical impulses from the pulse generator to the right ventricle
  • Dual chamber pacemaker – Carries electrical impulses from the pulse generator to both the right ventricle and the right atrium
  • Biventricular pacemaker – Stimulates both of the lower chambers of the heart (right and left ventricles). Because this treatment resets the ventricles’ pumping mechanism, it is also referred to as cardiac resynchronization therapy (CRT).

Pacemakers are manufactured by a variety of medical device companies, but most notably, the pacemakers manufactured by St. Jude Medical, Inc. have recently become the subject of litigation for putting patients in serious danger.

St. Jude ICDs manufactured before May 2015 feature a faulty battery design that makes them prone to short circuiting, which can cause total battery failure in as little as 24 hours. This gives patients very little warning to have the batteries replaced, and puts them in danger of heart attack or death due to device failure.

What are the Complications of Pacemakers?

Typically, the surgery to implant a pacemaker is very low-risk, but uncommon complications include:

  • Infection at the implant site
  • Swelling, bruising, or bleeding at the generator site
  • Damage to blood vessels or nerves near the pacemaker
  • Collapsed lung
  • Allergic reaction (to the dye or anesthesia used during surgery)

Unlike typical pacemaker procedures, St. Jude pacemakers present serious complications to patients. The design of the device’s battery lends itself to the formation of lithium clusters, which can cause the battery to short circuit and quickly lose all its power.

Although a St. Jude ICD battery can deplete rapidly and die with very little warning, there are some physical symptoms that may appear if the battery has short-circuited. These symptoms include:

  • Lightheadedness
  • Dizziness
  • Loss of consciousness
  • Chest pain
  • Shortness of breath

If the battery dies and the pacemaker is unable to provide necessary pacing or shocks, the patient could suffer a heart attack or even death.

Have Pacemaker Devices Been Recalled?

The FDA has responded to the dangerous nature of St. Jude pacemakers by recalling nearly 400,000 devices.

The FDA also sent a warning letter to St. Jude in April 2017, reprimanding them for improperly categorizing battery failures and waiting too long to recall the devices. The FDA stated that the company had violated good manufacturing practice requirements.

There is evidence that St. Jude was aware of the devices’ defect for more than three years before recalling the device. During that time they continued to sell the pacemakers and market them as safe, viable options for patients.

What are the Criteria for Filing a St. Jude Pacemaker Lawsuit?

If you or a loved one were dependent on a St. Jude ICD and were harmed by its defective battery, you could be entitled to compensation. The criteria for filing a lawsuit against St. Jude include the following:

  • Must have received one of the recalled St. Jude devices manufactured before May 2015:
    • Fortify VR
    • Fortify ST VR
    • Fortify Assura VR
    • Fortify Assura ST VR
    • Fortify DR
    • Fortify ST DR
    • Fortify Assura DR
    • Fortify Assura ST DR
    • Unify
    • Unify Quadra
    • Unify Assura
    • Quadra Assura
    • Quadra Assura MP
  • Underwent premature replacement surgery
  • Suffered heart attack or death due to device failure and/or emergency replacement of device due to premature battery depletion

In order to confirm that your device was included in the recall, you can enter the model number and serial number into this website.

Can I File A Defective Pacemaker Lawsuit?

Our dangerous device attorneys can help if you or someone you care about was harmed by a pacemaker device.

Lawsuits have been filed against St. Jude by both patients and their families seeking compensation for injuries caused by the dangerous pacemakers. You may be entitled to a settlement.

We do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it all in writing for you.

Our defective pacemaker lawyers will help you file your lawsuit.

Our No-Fee Promise on Pacemaker Cases

You can afford to have our great team of lawyers on your side. When you choose us, it literally costs nothing to get started. We promise you in writing:

  • No money to get started
  • We pay all case costs and expenses
  • No legal fees whatsoever unless you receive a settlement
  • Phone calls are always free

How Do I Start A Pacemaker Claim?

Our St. Jude pacemaker lawyers will help you file your lawsuit. To get started, you can:

  1. Submit the Free Case Review Box on this page, or
  2. Call (866) 280-3417 any time of day to tell us about your case.

We will listen to your story and answer your questions. If you have claim, we will start immediately.

WARNING: There are strict time deadlines for filing pacemaker injury lawsuit claims.

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