The Food and Drug Administration ordered St. Jude Medical on Thursday to conduct additional studies on patients implanted with heart-device components that were recalled last year and that have been linked to as many as 20 deaths. It also recommended that patients receive X-rays or other imaging to check for problems with their devices.
The Riata lead, which St. Jude stopped selling in 2010, is a wire that connects a defibrillator to a patient’s heart. Internal wires in the lead have been shown to break through the protective outer coating and cause unintended shocks in some patients. Defective leads may also prevent the defibrillator from working when needed by the patient. Defibrillators deliver a jolt of electricity to interrupt a potentially fatal heart rhythm.
