On January 17, 2017, St. Jude Medical Inc. announced it would recall 400,000 implanted cardiac devices because of premature battery depletion, a situation linked to two fatalities in Europe. The U.S. Food and Drug Administration (FDA) has categorized this as a Class 1 recall. Class 1 is the most serious type of recall that signals that use of these devices may result in serious injuries or death.
Function of Cardiac Defibrillators
St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are medical devices that regulate the heart. Cardioverter is actually synonymous with defibrillator and just means conversion of one cardiac rhythm to another. For slow heart beats they provide pacing and pacing or electrical shock to stop chaotic or rapid heart beats.
Ventricular arrhythmias impair the pumping efficiency of the heart and greatly increase the risks of fainting (syncope) and sudden cardiac arrest. Arrhythmias tend to develop in people with coronary artery disease and heart muscle diseases (cardiomyopathies), according to MedicineNet.com.
A defibrillator may be implanted within the body by far less invasive techniques than in the past as the devices, aside from being more technologically advanced, are smaller in size. An implantable defibrillator is approximately the size of a pager.
Both ICDs and CRT-Ds are implanted in the upper chest area under the skin, usually just below the collarbone, with connecting insulated “leads” (wires) that go inside the heart. The defibrillator can be installed through blood vessels, eliminating the need for open-chest surgery, according to the American Heart Association. An ICD or CRT-D is needed if a patient’s heart beat is too slow (bradycardia), too rapid (tachycardia), or requires coordination to treat heart failure.
Parker Waichman LLP has successfully represented individuals who have suffered from injuries allegedly associated with medical device products, including implantable heart defibrillators.
Recalled Defibrillator Models
Certain models of the St. Jude Medical devices are being recalled due to reports of rapid battery failure. The recalled models include Fortify, Unity, and Assura ICDs and CRT-Ds. The rapid battery failure is caused by lithium deposits, called “lithium clusters,” that form within the battery and create a short circuit.
A life-threatening situation can occur if the ICD or CRT-D battery unexpectedly runs out and the patient is unaware of the rapid battery drain. If the drained battery is not replaced, the implants will be unable to deliver the vital pacing or shocks. This could ultimately lead to a patient’s death.
Previously Reported Complications and Risks
St. Jude Medical previously reported two deaths that were caused by early lithium battery depletion. As of October 2016, there were still 349,852 affected devices actively implanted worldwide, with 251,346 of the devices to be recalled in the United States.
The specific models that were involved in the recall were manufactured between January 2010 and May 2015 and distributed between February 2010 and October 2016.
St. Jude Medical sent notification letters to customers and health care providers on October 10, 2016, informing them of the potential of premature battery depletion in certain ICD and CRT-D devices.
On October 11, 2016, the FDA issued a safety alert communication to patients, caregivers, and physicians, recommending that they respond immediately to elective replacement indicator alerts from the ICD devices.
Risks associated with ICD implantation are uncommon but may include: infection at the implant site; allergic reaction to the medications used during the procedure; swelling, bleeding or bruising where the ICD was implanted; damage to the vein where the ICD leads are placed; bleeding around the heart, which can be life-threatening; blood leaking through the heart valve where the ICD lead is placed; and collapsed lung (pneumothorax), according to the Mayo Clinic.
The American Heart Association recommends that before a patient is considered to be a candidate for an ICD, the arrhythmia in question must be life-threatening and doctors have ruled out correctable causes of the arrhythmia, such as: acute myocardial infarction (heart attack); myocardial ischemia (inadequate blood flow to the heart muscle); and electrolyte imbalance and drug toxicity. Patients are advised to understand and be aware of any underlying condition, such as genetic predisposition for risk of sudden cardiac arrest. ICDs are used primarily to prevent sudden cardiac death, according to the American Heart Association.
Do You Seek Legal Advice Concerning a Cardioverter Defibrillator?
If you or someone you know has been affected by a defibrillator injury, you may have valuable legal rights. Parker Waichman LLP is a nationwide, renowned personal injury law firm that has successful experience handling device injury cases. We urge you to contact the Parker Waichman medical device injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).