Researchers in Ireland have discovered a possible problem with a heart defibrillator component made by St. Jude Medical Inc. in which wires that run from the device to the heart may poke through the outer coating of their cable.
The study looked at 212 patients in Ireland who received St. Jude's Riata defibrillator lead and found that 15 percent had suffered such an "insulation breach," which could interfere with the device's life-saving therapy. Normal screening of the device or even X-rays may not pick up the breach, and patients would have no outward clue that their lead wire may be compromised.
"It could ultimately be a big issue, but we're just starting to scratch the tip of the iceberg of what the scope of the problem is," said Dr. Laurence Epstein, chief of the Arrhythmia Service at Brigham and Women's Hospital in Boston. "The downside [of the Irish study] was that it was a very small sample size and it was only one center."
Little Canada-based St. Jude said in a statement, "We are aware of these reports and have been working with this center to learn from their experience."
