Parker Waichman Warns of Potential Defect Tied To St. Jude Heart Device

Some St. Jude implantable cardioverter defibrillators may experience premature battery failure, which has led to multiple injuries and two deaths.

Port Washington, United States – October 13, 2016 /PressCable/ —

Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective medical devices, is warning patients of new safety concerns associated with two of St. Jude Medical Inc.’s implantable cardioverter defibrillators. The lithium batteries in some cases has led to two patients deaths and a recall issued by St. Jude, according to an October 11, 2016 report by QMed. The ICDs and CRT-Ds are devices implanted under the skin in the upper chest; leads are placed in the heart. ICDs and CRT-Ds are implanted in patients who are diagnosed with bradycardia (slow heart rate) or tachycardia (rapid heart rate) or who require coordination to treat heart failure.

The batteries may deplete within 24 hours of the recalled St. Jude implantable cardioverter defibrillators’ low-battery alert. The batteries are meant to provide charges to the devices’ capacitors. This, in turn, delivers the high-voltage shock designed to return a patient’s heart to a normal rhythm. Meanwhile, the chemical reaction that occurs causes formation of lithium particles. These particles may accumulate in an area that will lead to a short circuit, said Avi Fischer, MD, St. Jude’s medical director and vice president of global education and an electrophysiologist, QMed reported.

St. Jude indicated that it corrected the problem in May 2015 and removed the affected heart devices from distribution and hospital inventories, according to an October 11, 2016 report by The Associated Press (AP). Meanwhile, QMed notes that total number of devices experiencing premature battery depletion is not known, according to the U.S. Food and Drug Administration (FDA) and 349,852 St. Jude implantable cardioverter defibrillators are actively implanted worldwide. St. Jude officials have not named its battery manufacturer.

Federal regulators and St. Jude issued an alert to patients, caregivers, and physicians. The alert asked for an immediate response to elective replacement indicator alerts (ERI), writing that, “Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert,” according to the agency, QMed reported. The St. Jude implantable cardioverter defibrillators are meant to vibrate when the battery runs low and patients are instructed to advise their physicians immediately upon vibratory alert. Premature battery depletion monitoring may also occur during physician appointment and remote monitoring. Early depletion, according to the QMed report, involves devices manufactured prior to May 23, 2015 and include the 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.

St. Jude noted that, in addition to the two deaths, 10 more patients fainted when the devices stopped working, according to an October 11, 2016 report issued by (AP). St. Jude announced that the batteries should be replaced immediately upon the vibration alert issued by the ICDs or CRT-Ds. The metallic St. Jude ICD and CRT-D implants treat dangerous heart rhythms that may cause cardiac arrest, heart failure, and death, noted the AP. Federal regulators do not recommend patients implanted with the recalled St. Jude ICDs and CRT-Ds have them removed proactively as the surgical risks may outweigh the devices’ risks.

According to Parker Waichman, recalls may affect litigation involving medical devices. “Recalls generally indicate that federal regulators and the device manufacturer recognize that a serious problem exists with the recalled medical devices and note the importance of removing potentially dangerous devices from the market,” said Keith Gitman, Managing Attorney at Parker Waichman.

Parker Waichman LLP offers free lawsuit consultations to victims of medical device injuries and complications. For more information concerning reactions to the St. Jude implantable cardioverter defibrillators, please visit the firm’s Defective Medical Devices page. Free case evaluations are also available by calling 1-800-LAW-INFO.

For more information, please visit http://www.yourlawyer.com/long-island

Contact Info:
Name: Parker Waichman
Organization: Parker waichman LLP
Address: 6 Harbor Park Drive Port Washington, NY
Phone: (516) 466-6500

Release ID: 138266