Medtronic suspended sales and recalled all unused Sprint Fidelis leads on October 15 after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. In the worst case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. Yet replacing a lead is more risky than having a defective lead.
Medtronic has known about the problem as of January 2007 as 599 lead fracture problems have been reported to Medtronic. Reports of problems have increased over time as more people have been implanted with Sprint Fedelis leads. Since January 2007, there has been an explosion of reports of fractures - 1,030 reports.
Shortly after the Sprint Fidelis lead recall; it was revealed that the FDA had not required extensive testing of the vital defibrillator component before it went on the market. Although the agency had required Medtronic to test an earlier version of a defibrillator lead in patients before approval, it had not required the company to do so for the defective Sprint Fidelis lead.
The Congressional Committee is investigating why the FDA's failed to rigorously test the Sprint Fidelis lead and why all defibrillator leads are not subject to the same level of scrutiny as heart devices.
see: http://www.newsinferno.com/archives/1944
