According to a recent Bloomberg article, a study found that the recalled St. Jude Medical Inc. (“St. Jude”) wires, still in use to connect life-saving defibrillators to the hearts of 79,000 patients, had multiple defects that led to melted conductors, electrical abnormalities, and shocks.
St. Jude stopped selling its Riata wires in December 2010, and recalled them last year on reports that the wires could break through their insulation. United States regulators have reported that surgery to remove the leads may present higher risks than keeping them in.
A study of 105 reports on failed wires found that two-thirds had multiple defects. The study reported at an American College of Cardiology meeting indicated that the wires can produce static like noise which may result in unnecessary shocks or reduce the energy needed to stimulate the heart.
A separate analysis from researchers in Northern Ireland presented at the same meeting that 2.6 percent of patients with the leads develop protruding wires each year, and 19 percent of patients have the complication. St. Jude is conducting a clinical trial with more than 500 patients to determine how frequent the problem occurs and what happens to the wires over time.