Medtronic Spring Fidelis Defibrillator Lead Recall Proves ‘FDA Approved’ Means Nothing
November 19th, 2007 amy
The latest Medtronic Defibrillator recall, involving defective Sprint Fidelis leads which can detach inside a patient’s body and cause death or severe shock injury, proves the Food & Drug Administration (FDA) isn’t doing its job. At least five deaths and thousands of injuries have been reported due to the defective Medtronic Sprint Fidelis Defibrillator leads, and the FDA received many of these reports almost a year before issuing the Medtronic Defibrillator recall.
People assume that as long as a food, toy or medical device has the FDA’s stamp of approval that it’s safe. Not the case. People also assume that when a product is found to be dangerous that it’s recalled right away so no one else will get hurt. Definitely not the case with defective Medtronic Defibrillator Leads implanted in hundreds of thousands of people worldwide.
When it comes to a medical device surgically implanted into a patient’s body, one would think the FDA would be a little more careful. Instead, over a hundred thousand people in the United States alone walk around today with a potentially life-threatening defibrillator attached to their hearts, even after the Medtronic Defibrillator recall. It is more dangerous to have the defective device removed than to keep it in and just hope the defibrillator keeps working. For patients who have yet to have their defibrillators dangerously shock them or stop working altogether, they must continue to keep these defective devices in their bodies and worry whether this will be the day their defibrillators kill them.
Several Medtronic lawsuits have already been filed by people who have been injured, but many people still aren’t sure whether or not their defibrillator was one affected by the latest Medtronic Defibrillator recall. The number of the recalled models is 6930, 6931, 6948 and 6949. This information can be found on the card given to patients after the surgery. Patients who don’t have their cards or who are concerned whether their defibrillator was recalled should contact their doctors. Anyone who has been injured should consider speaking with an attorney.
