Fridley-based Medtronic says the company's Sprint Fidelis cardiac wire may have played a role in the deaths of more people than it previously indicated.
When Medtronic stopped selling the wire in October 2007, it was connecting a defibrillator to the heart of some 270,000 patients. The company estimated five people might have died as a result of malfunction. Medtronic spokesman Chris Garland said an independent panel of physicians reviewed recent reports about the device and found the lead was a likely factor in more deaths.
"The panel was able to make the determination that Sprint Fidelis may have been a possible or likely contributing factor in 13 patient deaths, total," Garland said. "The panel noted that four of those deaths were associated with lead extraction. That's actually removing the lead from the body."
Carpenter said the panel reiterated that the device should be left in place if it is performing as it should be. He said that's the case about 96 percent of the time.
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