CRM device leads
Leads in the past have been a problematic component of cardiac rhythm management devices, dogging the medical device companies that make them.
One of the worst recalls occurred in 2007, when Medtronic pulled its Sprint Fidelis defibrillator leads from shelves worldwide. Already inside an estimated 268,000 people, the leads were suffering wire fractures that affected device performance — causing unnecessary shocks or no shock at all when a shock was necessary, MDO’s sister site MassDevice reported back in 2010.
More than 100 deaths occurred around the Fidelis leads, though Medtronic said that the leads were a “possible or likely contributing factor” in only 13 of the fatalities.
Fidelis-related lawsuits, however, didn’t fare well after the U.S. Supreme Court’s Riegel v. Medtronic decision in 2008. The case barred state lawsuits involving medical devices with PMAs from FDA. Medtronic settled Sprint Fidelis suits for $268 million in 2010.
Medtronic isn’t the only company that has run into problems with defibrillator leads. St. Jude Medical, now part of Abbott, pulled its silicone-coated Riata and Riata ST leads from the market in 2010. Some of the internal conductors had worn through their insulation, a situation that could cause unwanted shocks.
