Patients who have Medtronic’s
Sprint Fidelis defibrillator leads implanted have reported overwhelming feelings of emotional distress due the company’s handling of the problem. Medtronic recalled
Fidelis lead model numbers 6930, 6931, 6948 and 6949 on October 15, 2007 after several patients complained about being repeatedly jolted by the allegedly defective leads.
Experts say that Medtronic’s estimates may be low
Medtronic has said that it estimates that approximately 2.3% of those patients affected by the recall may have a fractured lead. That amounts to between 4,000 and 5,000 patients of the 235,000 that were implanted with the leads since they were approved by the Food and Drug Administration (FDA) in 2004.
However, plaintiff attorneys think those estimates might be low as companies that recall products – especially those with potentially serious consequences such as this – are often conservative on their estimates for the sake of ‘damage control’. The company has also said that the Fidelis leads may have caused five deaths. Again, plaintiff attorneys have said that this number might also be conservative.
Emotional distress
Many patients have reported feeling overwhelming emotional distress due to the nature of the recall. Patient’s who experience, or may experience, a lead fracture must undergo risky surgery to have the problem corrected. They have reported feeling fearful of having another surgery because of what could happen when they are on the operating table – such as having a heart attack, stroke or getting an infection. Even if some of these circumstances are unlikely to occur, it doesn’t mean that patients aren’t experiencing legitimate fear.
Even patients who don’t need to have surgery report that they’re nervous about the future. As Medtronic has recalled other products in the past, some patients simply don’t trust the company anymore. This, coupled with the countless reports of patients being unnecessarily shocked (some have reported feeling as though they were experiencing a heart attack), anyone can see why some patients feel the way they do.
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