A society of heart doctors wants manufacturers of defibrillator leads to improve monitoring of the devices once they hit the market, following Medtronic Inc.’s revelation that 13 patients died (subscription) after its Sprint Fidelis defibrillator leads fractured.
The Heart Rhythm Society, which issued the recommendation at its conference this week in Boston, said manufacturers and the Food & Drug Administration need to cooperate in creating a post-market surveillance program for the devices.
“All the stakeholders agree that we need to do a better job,” William Maisel, a cardiologist at Beth Israel Deaconess Medical Center and co-chairman of the group’s panel told the Wall Street Journal. “There needs to be formal post-market surveillance for every model of lead, not just waiting for something to happen, but to actively provide surveillance for every model.”
In March, Medtronic said 13 people died after fractures appeared in the leads, which connect defibrillators with the heart muscles they’re designed to shock back into rhythm. The company said the wires were a “possible or likely contributing factor” in the deaths. Four of the deaths occurred during extraction surgery to remove the leads.
Medtronic pulled the Sprint Fidelis leads from shelves worldwide in October 2007, but not before they were implanted in an estimated 268,000 patients. Because of the fractures in the wires, defibrillators can either fail to deliver the shock needed to regulate a haywire heartbeat or send unneeded shocks that can kill.
Robert Hauser, Maisel’s co-chairman on the Heart Rhythm Society panel and a cardiologist at the Minneapolis Heart Institute, told the Journal he learned of the Sprint Fidelis problems months before the Minneapolis company shelved the device.
The panel also wants the FDA to regulate when manufacturers must run human clinical trials after changing their devices’ designs. Hauser chastised the federal watchdog last year for allowing device makers to alter the connection between defibrillators and leads without running human trials.
Another of the society’s panels wants to set up a national registry for lead extraction surgeries that would publicly disclose outcomes and recommended that no surgeon take the lead in extractions without assisting in a minumum of 40 procedures.
A Medtronic spokesman told the Minneapolis Pioneer Press that although the company is still reviewing the guidelines, it’s generally supportive and is already a leader in tracking defibrillator leads after implantation.