FDA Warns About Defibrillators
Tragically, two people recently lost their lives after the batteries in their implanted heart defibrillators failed to function properly. As a result, the manufacturer, St. Jude Medical, has issued warnings to patients that around 400,000 devices may be defective.
How Are the Defibrillators Malfunctioning?
According to the Food and Drug Administration (FDA), the batteries in affected defibrillators die without warning. If the devices operated properly, the Elective Replacement Indicator (ERI) would send out a notification three months before the defibrillator battery was depleted. When the battery dies in a defibrillator, the ICD or CRT-D device is unable to deliver life-saving pacing or shocks, according to the FDA. This is extremely dangerous and can result in fatality for the patient.
In addition to the two patients who lost their lives as a result of their pacemakers malfunctioning, ten American patients have reported fainting and 37 who became dizzy when their defibrillators did not function as intended.
According to St. Jude, the company has sold close to 400,000 devices internationally, but only one percent of these are actually faulty. So far, this problem has only affected devices produced prior to May 2015.
Which Devices Are Affected?
The affected devices are manufactured by St. Jude Medical, and include the Implantable Cardioverter Defibrillator (ICD) and the Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. Although St. Jude Medical is not recommending that patients who have the devices already implanted have them removed, physicians are advised to get in touch with their patients fitted with the defective devices and ensure that they are working properly.
Who Is at Risk?
Patients are most at risk are those who are pacemaker dependent, or have a high likelihood of requiring life-saving shocks. Patients who are pacemaker dependent with a device that has reached Elective Replacement Indicator should be treated as a medical emergency, according to the FDA.
The company maintains that most patients should be fine, and has released a statement that the likelihood any patients will be affected is very low. They maintain that the vast majority of devices have not experienced premature battery depletion.
New Brunswick Personal Injury Lawyers at the Law Offices of Harold J. Gerr Win Compensation for Victims of Defective Medical Devices
Tragically, the devices we trust to keep us healthy do not always function as intended. If you have sustained an injury as a result of a defective medical device, call the experienced New Brunswick personal injury lawyers at the Law Offices of Harold J. Gerr at 732-537-8570, or contact us online today. With offices located in Middlesex County, New Jersey, we help clients throughout New Jersey hold responsible parties accountable.
