An implanted heart defibrillator component may be responsible for 22 deaths (and could affect any number of the estimated 20,000 patients who have the devices implanted), according to a study printed in the medical industry journal Heart Rhythm. The device is designed to avoid cardiac arrest in high-risk patients by sending an electrical current through an irregularly beating heart to restore it to a normal pace. Researchers allege that a short circuit in the device is keeping it from sending the current out when necessary, leading to patient death.
If the allegations are supported, the defibrillator may be classified as a defective product. The medical device is also under scrutiny by the FDA, who recently issued a recall.
How the Defect Led to Fatalities
The device, known as the Riata and Riata ST, is manufactured and distributed by St. Jude Medical, Inc., and is composed of two parts. The first is a small canister that is inserted underneath the patient’s collarbone and the second consists of two wires that enter blood vessels leading to the heart. The wires are designed to send an electric shock to the patient’s heart when the rhythm is abnormal.
Unfortunately, two defects have been noted in these devices. The first, a breakdown in the silicone insulation around the wires, does not appear to be problematic at this time even though the insulation was designed to safely encompass the wires within the patient’s body. The second defect, though, is a short circuit that might cause the device to fail; this one is causing concern among medical professionals and patients alike.
If a short circuit occurs, the device is no longer able to produce the life saving electrical current to “jump start” the heart back in to a normal rhythm. Without the shock, the patient’s arrhythmia can go uncorrected, and the patient is at an increased risk of death.
If you or a loved one experiences an injury as the result of this or a similar faulty medical device, compensation is likely available to cover medical and rehabilitative expenses as well as pain and suffering. In order to determine the best course of action, it is wise to seek the counsel of an experienced products liability attorney in your area.