As early as January of 2007, hospitals began seeing problems in patients with Medtronic implanted defibrillators who were experiencing severe electrical shocks.
The shocks were caused by broken wires, called a lead, which tells a defibrillator when to send an electrical shock to a malfunctioning heart. The Minneapolis Heart Institute concluded that the Medtronic Sprint Fidelis defibrillator wasn’t safe, stopped using the product, and notified Medtronic, Inc. of its concerns.
The Wall Street Journal reported that leading hospitals across the country encountered similar problems and took similar steps. What did Medtronic, Inc. do? Nothing for way too long! It wasn’t until October 7, 2007 before Medtronic decided the company should suspend sales of the Fidelis leads. In one of the biggest recalls of a medical device, Medtronic pulled all Sprint Fidelis models from the market…citing 5 deaths in the devices’ 3 years on the market.
The Food and Drug Administration (FDA) let the American public down once again!