|
Medtronic defibrillator wire injury reports up in 2007 |
|
Tuesday, 16 October 2007 |
The number of injuries reported by patients wearing the defibrillator wires involved in the recent Medtronic recall rose drastically between 2006 and 2007, one consumer group says. Public Citizen says that according to Food and Drug Administration statistics, the agency received injury reports from 1,194 patients wearing a Sprint Fidelis lead wire during the first 10 months of 2007. This represents a sharp increase from the 296 reports of defibrillator wire problems issued during a similar period over the previous year.
Public Citizen says that the number of inappropriate patients shocks—when the defibrillator shocks the heart when it is not supposed to—rose even more sharply than the total number of injuries. Medtronic recalled the Sprint Fidelis lead wire this week after it was linked to the deaths of at least five patients wearing the devices.
In a letter to FDA chief Andrew von Eschenbach, Public Citizen health director Dr. Sidney Wolfe questioned why the FDA did not issue a Medtronic defibrillator recall after receiving the numerous injury reports.
“Why did the FDA, aware of the rapidly mounting number of injury reports, not force the company to recall defibrillators not yet implanted in the early part of the year?” Wolfe wrote. |