As coronary patients who have been implanted with Medtronic defibrillator leads scramble to see their doctors after the company recalled their
Sprint Fidelis leads, many just want to know the facts about lead replacement. Here’s what’s known:
How to know if your lead is defective
Although the Food and Drug Administration (FDA) has said that there is not a specific test that can determine whether a certain Sprint Fidelis lead is defective, it’s been reported that doctors can perform a procedure that adjusts a patient’s defibrillator settings to increase the likelihood that a fracture will be detected before a patient is harmed.
Some patients have written in blogs that they simply don’t know what type of lead they have. Although not common, Fidelis leads may be used with another company’s defibrillator device. So, if you don’t know or aren’t sure what kind of lead you have – ask your doctor.
What to do if you have a defective lead
If you have a defective Sprint Fidelis lead, you can either have the lead replaced or capped. Doctors have differed on which avenue is best, but both require surgery – which could be dangerous as leads attached to the heart sometimes scar and disturbing that scar tissue may increase the likelihood of injury.
Medtronic says that it will replace defective Fidelis leads with their older version of the product, the Sprint Quattro. The company will pay for the procedure and $800 towards any uncovered insurance expenses.
Note: Although the company says that it will replace defective Fidelis leads with Quattro leads, the company has also reported that it does not have enough Quattro leads to go around. However, they expect to within the next several months.
What to do if you don’t have a defective lead, but want a replacement
If don’t have a defective lead, but want a replacement anyway, you’re basically on your own. Medtronic has said that it will not pay to have non-defective leads replaced – a move that has angered some patients who simply no longer trust the quality of the product.
What else can you do?
Reports indicate that the company knew about the defect well in advance of the actual recall. Several lawsuits have already been filed against Medtronic for knowingly selling a defective product, negligence and emotional distress. If you or a loved one has been injured in any way as a result of Medtronic’s Sprint Fidelis lead, contact an attorney whose practice focuses in this area of the law. To contact an attorney near you, click here.