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. If you have suffered harm after being treated with this device, contact pacemaker lawyers to discuss your legal rights and options.
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.
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. The lithium cluster battery failure was identified by physicians at Duke University in a 2014 publication, and there is evidence that St. Jude knew of the issues even before then. During that time they continued to sell the pacemakers and market them as safe, viable options for patients. To learn more about how a Pacemaker recall can impact your case, speak with one of our knowledgeable lawyers.
Reported 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.
Pacemakers are designed to provide ample warning, usually three months in advance, of impending battery depletion. St. Jude Pacemaker devices have been found to feature a defective battery design that can short circuit and cause total battery failure in as little as 24 hours.
The batteries in these St. Jude pacemaker devices are Q High Rate batteries, and it is this QHR technology that is suspected to cause the lithium cluster formation. Interestingly, the QHR batteries were not featured in the devices when they were initially approved by the FDA. St. Jude later updated the pacemakers to include the QHR batteries, which they claimed to be novel technology that would increase battery life.
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:
- 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. Anyone who has experienced adverse effects from these pacemakers should reach out to a dedicated lawyer for help.
There are four main symptoms/signs that you may be having a heart attack:
- Chest discomfort: The majority of heart attacks involve mild pain or discomfort in the center of the chest that lasts more than a few minutes, or that comes and goes in waves. It can feel as though there is an uncomfortable pressure, squeezing, fullness or pain.
- Discomfort in other areas of the upper body: Some areas where you may feel discomfort or pain may be in one or both arms, the back, neck, jaw or stomach.
- Shortness of breath: This includes shortness of breath with or without chest discomfort.
- Other common signs: May include breaking out in a cold sweat, nausea or lightheadedness.
Our Pacemaker Attorneys Can Help You Demand Justice
If you or a loved one were dependent on a St. Jude ICD Pacemaker and were harmed by its defective battery, you could be entitled to compensation with the help of an attorney. 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 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 on this website. A pacemaker lawyer can help you hold the manufacturers accountable if you have suffered adverse health effects from this device.