St. Jude Medical Inc. has recalled 400,000 implanted heart devices because of the risk of premature battery depletion. The defect is linked to two deaths in Europe.
The devices included in the recall are St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). These implantable devices provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
Battery Issue Revealed in 2014
The Minneapolis Star Tribune reports that the battery issue was first revealed in a December 2014 journal article. St. Jude changed the device design to reduce the risk of rapid battery depletion, but the company acknowledged it continued to ship old devices for 17 months after changing the design.
The U.S. Food and Drug Administration (FDA) has categorized the recall as Class I, the agency’s most serious recall category. Use of the affected devices may cause serious injuries or death. The knowledgeable device-injury attorneys at Parker Waichman can answer questions from individuals who are considering filing a St. Jude Medical ICD or CRT-D lawsuit.
ICDs and CRT-Ds are implanted under the skin in the upper chest area with connecting insulated wires—leads—that go into the heart. Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or the heart needs coordination to treat heart failure.
Lithium batteries provide charges to the capacitors that deliver the high-voltage shocks that bring a patient’s heart to normal rhythm. But in the recalled St. Jude Medical ICDs and CRT-Ds, a chemical reaction in the battery results in the formation of lithium particles that can cause a short circuit and lead to premature battery depletion. At the time the patient receives the battery alert, the patient is supposed to have up to three months to to replace the battery.
Recalled St. Jude Medical Cardiac Devices
Devices covered under the recall include St. Jude’s Fortify VR, Fortify ST VR, Fortify Assura VR, Fortify Assura ST VR, Fortify DR, Fortify ST DR, Fortify Assura DR, Fortify Assura ST DR, Unify, Unify Quadra, Unify Assura, Quadra Assura, and Quadra Assura MP. The devices were recalled after reports of rapid battery failure caused by deposits of lithium (“lithium clusters”), forming within the battery, and causing a short circuit. If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to replace the battery, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to the patient’s death.
In addition to the two reported deaths, the FDA reports that 10 patients have fainted because the device did not providing pacing therapy. Thirty-seven other patients say they experienced dizziness from lack of pacing. But the FDA notes that more patients have likely been affected. Not all instances of battery depletion were reported, the FDA says.
A patient with an ICD or CRT-D typically gets a battery alert that allows three months lead time for battery replacement. With the recalled St. Jude Medical devices, however, the battery has sometimes lost power as soon as 24-hours from the time the patient receives the alert, although the patient believed he or she had a number of weeks to replace the battery. A chemical reaction that causes deposits of lithium can cause a short circuit in the device that is responsible for the rapid battery failure. If the battery drains completely before the patient can replace it, the defibrillator will not be able to perform the necessary pacing or shocks, and this could result in the patient’s death.
The recalled St. Jude Medical ICDs and CRT-Ds were manufactured between January 2010 to May 2015, and distributed from February 2010 to October 2016. More than 250,000 devices were recalled in the U.S., with about 150,000 more of these devices recalled worldwide.
St. Jude Medical recommends that patients program their ICD or CRT-D device to deliver vibratory alerts and use the St. Jude Medical home monitoring system to monitor battery status. Some patients, however, may not detect the alert before battery depletion, and such monitoring may not be sufficient for patients who are dependent on the devices for pacing, according to the FDA. The FDA recommends that doctors determine whether their patient’s device should be replaced.
Legal Help for Those Harmed by a St. Jude Medical ICD or CRT-D Device
If you or someone you know has been injured or suffered adverse health consequences because of a St. Jude Medical implantable device, please contact the attorneys at Parker Waichman LLP for a free, no obligation evaluation of your legal rights. To reach the firm, fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).