St. Jude’s Defibrillator Leads: Information for Patients
By Christopher Weaver
Just as the dust appeared to be settling from St. Jude Medical Inc.’s months-long saga over a troubled heart-device, U.S. regulators sent a warning shot that could rattle doctors and patients.
The agency advised doctors to begin routinely screening the nearly 80,000 U.S. patients who have Riata defibrillator leads in their chests with X-rays to search for signs that a device’s insulation is wearing away. FDA officials also pressed the company to amp up studies for both the flawed Riata device and its successor, Durata-series leads, which have not yet been linked to problems.