Medtronic has issued a product recall for Sprint Fidelis Defibrillator leads because of possible fractures in the lines. The defibrillator leads have been on the market since 2004 and the FDA did not require human testing before gaining approval. The model was close enough to a previous one to not warrent it. Medtronic did perform short-term testing on humans before seeking FDA approval though.
Before approving the Sprint Fidelis models, the FDA reviewed results from animal tests and extensive engineering “bench” studies, including 400 million repetitions of a bending motion designed to answer questions about the devices’ strength, said Megan Moynahan, chief of the FDA branch that oversees defibrillator leads. Because the fracturing issue is “extraordinarily rare,” a human clinical trial was unlikely to find it, she said.
There are 235,000 of the recalled items still being used in people. Five people may have died from using the device. The leads are connected to a defibrillator implanted in a person’s chest.