Following a warning issued earlier this month about a risk of sudden battery problems with St. Jude heart implants, federal regulators have announced a class I medical device recall, suggesting that the defect poses a serious and potentially life-threatening risk.
The FDA announced a St. Jude implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) recall on October 24, which impacts some of the company’s Fortify, Unify, and Assura heart implants.
The devices may experience rapid batter failure, which has already been linked to at least two deaths and dozens of adverse event reports.
According to the warnings, patients, caregivers, and doctors should respond immediately to Elective Replacement Indicator (ERI) alerts. Usually, these alerts go off three months before battery replacements are needed. However, the recalled St. Jude Fortify, Unify and Assura ICDs and CRT-Ds may have the battery die within 24 hours after the alert goes off, leaving patients without critical life-saving heart rhythm pacing or defibrillation shocks.
The St. Judge ICDs and CRT-Ds are implanted under the skin in the upper chest. They have lead wires that go to the heart and help regulate the heart’s rhythms through electric shocks.
According to the FDA, nearly 400,000 of the affected devices have been sold worldwide, and 841 of them have been returned due to problems with the lithium clusters causing the batteries to fail. The class I recall designation suggests that individuals with these devices still in place may be at risk of serious problems.
The FDA confirms that at least two deaths have been identified so far, including one in the U.S., which occurred after premature battery depletion when the St. Jude heart devices failed to give life-saving shocks. Another 10 patients, including 9 in the U.S., have reportedly fainted due to the same problems. Another 37 patients, including 30 in the U.S., have reported dizziness.
The recall affects certain St. Jude Medical ICD and CRT-D models manufactured before May 2015, including 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. A full list of the affected devices is located in the FDA recall notice.
In addition, St. Jude has created a premature battery depletion website to help patients determine if their ICD or CRT-D is affected by the recall.
The FDA is advising patients to contact their doctor if they feel a vibratory alert, register for St. Jude’s home monitoring program and to seek immediate medical attention if they experience lightheadedness, dizziness, loss of consciousness, chest pain, or severe shortness of breath.
The agency has advised health care providers not to implant unused affected devices, and that the problem appears to be restricted to devices made before May 2015. The FDA also advises doctors to warn patients with affected devices about the battery depletion risks, to immediately replace batteries in any devices that give an ERI alert, and to treat those cases as medical emergencies.
In addition, the FDA suggests doctors consider whether to replace the device on a case-by-case basis. In some cases, replacement may be preferable because of concerns of responding to an ERI alert in a timely manner. In other cases, the risk of heart surgery complications and the patient’s health may make keeping the current device in place the correct choice.
The FDA is asking that any adverse events be reported to its MedWatch adverse event reporting program.