Of all medical problems patients endure, those involving the heart are typically the scariest and the most stressful for the patient and their loved ones. The heart is such an integral part of the body that much care must be used when treating it. The heart is a very complicated organ. It has its own internal electrical system that controls the rate and rhythm of your heartbeat. With every heartbeat, an electrical signal travels from the top of your heart to the bottom, and as it spreads, it causes the heart to contract, therefore pumping blood throughout your circulatory system. For those patients who suffer from life-threatening cardiac dysrhythmias, ventricular fibrillation and other heart irregularities that often lead to cardiac arrest, a common treatment is defibrillation. Defibrillation consists of delivering a therapeutic dose of electrical energy (a “shock”) to the heart through a device called a defibrillator. This technique depolarizes part of the heart muscle and terminates the arrhythmia, allowing for normal rhythm to return. There are two types of defibrillators – external and internal. External defibrillators, also known as automated external defibrillators or AEDs, automate the diagnosis of treatable rhythms, allowing bystanders or medical responders to easily use them with little or no training. Internal defibrillators are pacemakers that are placed under the chest wall, with attached wires that are put inside the heart and instead of having an electrical shock outside of the heart, this defibrillator provides a shock that goes indie the heart muscle and stops the heart from beating erratically and helps it to begin beating rhythmically and regularly again. Defibrillators are incredible life-saving tools that save thousands of lives every year in the United States.
During the past few years, many patients have suffered unnecessary complications, including death, from faulty internal or external defibrillators. In 2010 the Food and Drug Administration warned that hundreds of thousands of external defibrillators may malfunction when used to help people suffering from sudden cardiac arrest. The FDA urged health care facilities to find replacement devices. The faulty devices did not properly administer the shock needed to revive hearts that had unexpectedly stopped beating. According to the FDA:
Faulty components in defibrillators manufactured by Cardiac Science Corp. of Bothell, Wash., may cause the devices to fail to properly deliver a shock. In addition to failure to deliver needed shocks, other problems with the affected models may include interruption of electrocardiography (ECG) analysis, failure to recognize electrode pads, and interference or background noise that makes the device unable to accurately analyze heart rhythm.
The 14 models, which include automated and semi-automated devices, are:
- Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
- CardioVive models 92531, 92532 and 92533
- Nihon Kohden models 9200G and 9231 and
- GE Responder models 2019198 and 2023440.
Faulty internal defibrillators have been identified as well. As stated earlier, there are wires that are put inside the heart, and these wires have, on occasion, poked through their outer casing, causing unwanted shocks or failed to work when needed. Unfortunately for those patients with these issues, there is no easy fix. Removing the wires can be dangerous, but leaving them in can be dangerous as well. Both options come with considerable risks. According to the FDA:
FDA notified healthcare professionals of a Class I Recall of the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads. The silicone insulation covering these defibrillation leads is at risk of premature abrasion. When abrasion occurs, the conductors inside the leads can come out (externalized) of the insulation. Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death.
The recall includes the following model numbers:
- Riata (8F) Silicone Endocardial Defibrillation Leads, Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
- Riata ST (7Fr) Silicone Endocardial Defibrillation Leads, Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042
If you, or a loved one, have been injured by a faulty defibrillator, please contact our office after seeking medical attention. At all of our convenient office locations our Miami defective product attorneys are committed to seeking the full compensation you are entitled to receive. We will work diligently on your case, but will do so on a contingency basis. This mean you only pay for services if we get you compensation. Please schedule a conference with us right now, free of charge, by calling 305-448-8585 or toll free at 877-448-8585.