The Problem & Recall
In October of 2016, St. Jude Medical recalled Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) for battery failure. The FDA has identified this as a Class I recall, signifying the use of St. Jude Medical defibrillators could cause life-threatening injuries or even death.
The ICD and CRT-D are defibrillators, also known as pacemakers, designed to regulate a patient’s heart rhythm. Pacemakers are implanted in the patient’s chest or abdomen and shock the patient with electrical impulses that contract the heart muscles. Pacemakers have batteries that are supposed to give a warning three months prior to battery failure. The problem with these St. Jude Medical defibrillators is that the batteries are suddenly and unexpectedly dies. If and when the battery dies, the pacemaker will not deliver the life-saving shocks it’s intended to, possibly leading to death.
Symptoms of a short-circuited St. Jude Medical defibrillator battery include lightheadedness, chest pain, loss of consciousness, and shortness of breath.
St. Jude Medical Defibrillators
St. Jude Medical has recalled nearly 400,000 defibrillators that were manufactured prior to May 2015. These defibrillators feature the faulty battery design, making users susceptible to short-circuiting.
The FDA sent a warning letter in October of 2016 to customers and health care providers stating that St Jude Medical had improperly categorized the battery failures of the devices. St. Jude Medical should have confirmed that the batteries had suffered from premature depletion. Instead, St. Jude Medical categorized the cause of the depletion as “unconfirmed,” allowing them to minimize the severity of the problem and continue selling the devices.
GoldenbergLaw Can Help
GoldenbergLaw has over 30 years of experience holding medical device manufacturers accountable for their negligence. We are committed to promoting safety through accountability. If you or a loved one has a recalled St. Jude Medical defibrillator and experience any of the above symptoms, contact us.