Year After Medtronic Lead Recall, Few Replaced
October 20th, 2008 laurie
A year after the big Medtronic defibrillator recall, only a few defective wires that connect defibrillators to hearts have been replaced, the Toledo Blade reports some Toledo cardiologists say.
Last October, Medtronic recalled its Sprint Fidelis lead, the wire connecting the implanted defibrillators to the heart, after four reports of death due to fracturing lead wires. In some cases, multiple heavy voltage shocks killed patients and in other cases the wires fractured and failed to deliver the lifesaving shocks the defibrillators were implant to deliver. Many who didn’t die were severely injured, but still were advised not to have their defibrillator lead wires replaced due to the fatal risks of having such a surgery.
The Toledo Blade now reports that at the University of Toledo Medical Center, the recalled Sprint Fidelis leads made by Medtronic were removed from three of 80 patients with them.
“If we electively started taking all the leads out, there would be significant morbidity and mortality,” said Dr. Kanjwal, who uses an ultraviolet laser procedure to help remove leads encased in heavy scar tissue. He added: “It is not an innocuous procedure.”
The Toledo Blade reports that St. Vincent Mercy Medical Center has had about four cases where questionable defibrillator leads were replaced out of nearly 500 patients with them, per Dr. Ameer Kabour, section chief of cardiology. Other patients with the Fidelis leads are monitored more frequently than usual, Dr. Kabour said. Some patients were concerned at first, but they have been reassured by explanations, he said. Two additional patients were referred to the former Medical College of Ohio for the operation for a total of five removals, UT cardiologist Dr. Yousuf Kanjwal said.
