Medtronic Faces More Problems with Cardiac Implant

Medtronic has called on doctors to stop using its implanted heart device, the Sprint Fidelis because of a defect in one of its leads. The lead which connects the heart to a defibrillator, is supposed to send an electrical pulse to shock the heart back into a normal rhythm. However, the defective lead is not doing that. Medtronic is asking that all 235,000 Sprint Fidelis patients contact their cardiologists to make sure that the device has not developed a crack which causes it to misread cardiac rhythms. The consequences of this defect can be fatal and have been in five cases. The Sprint Fidelis has been on the market since 2004 and most patients who received a Medtronic defibrillator have the Sprint Fidelis.
It appears Medtronic may have learned a lesson from Guidant Corp. in disclosing the defect fairly early on. Three years ago, Guidant knew of a defect in its defibrillators but delayed informing doctors. The fallout from that debacle may have spurred Medtronic to make a quicker, more proactive response.