FDA OKs Medtronic defibrillator upgrade

WASHINGTON, Sept. 4 (UPI) -- The U.S. Food and Drug Administration approved a software update to detect problems in some of Medtronic Inc.'s Sprint Fidelis defibrillators.

The FDA said the software will alert patients and physicians of a potential lead fracture.

"This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "While the software doesn't fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner."

Implantable defibrillators are used to treat patients at risk of experiencing life-threatening heart rhythm abnormalities. Should an abnormality occur, the defibrillator delivers a pulse of energy through a lead, a thin electronic wire, shocking the heart back into normal rhythm.

The Sprint Fidelis lead, the subject of an October 2007 recall, was prone to fracture in a small number of defibrillators, potentially causing the lead to deliver unnecessary shocks or not operate at all.

Medtronic's new software feature issues an audible alert once it detects signals that could indicate a lead fracture.