Plaintiffs in the Medtronic defibrillator litigation are seeking class action certification for their defective implantable defibrillators. Five deaths have already been attributed to broken wires in the leads of these Medtronic defibrillators. Regrettably, more are expected given that 235,000 Americans have the four Sprint Fidelis lead wires that even the company concedes are failing. Medtronic estimates that four to five thousand patients with the Sprint Fidelis lead will experience a lead fracture within 30 months of implantation. (You cannot help but assume this is low.)
The company is asking the 235,000 people with these defective electrical leads to have their physician evaluate whether their lead has developed a fracture. Certainly, you should contact your doctor if you do not know whether you have one of these defibrillators – many people do not know the brand of their defibrillator, much less details as to the component parts (although most patients have a wallet card that will specify the manufacturer of their defibrillator leads). The Sprint Fidelis leads that have been recalled have the model numbers 6949, 6948, 6931 and 6930.
Obviously, lead recalls are particularly serious given the difficulty to replace them. Should it be replaced if there is no evidence of a fracture? This is an issue that can and should be addressed with your doctor.
While Medtronic has not disclosed the precise mechanism of how these Sprint Fidelis lead fracture failures have failed, it appears that the defect is caused by the small diameter of the coil and conductors in the lead. Because of this, the lead is subject to stress damage both during and after the defibrillator is implanted. A lead fracture occurs when the conductor is critically overstressed. While only five deaths have been reported, many people are reporting repeated electrical shocks due to their lead having fractured.
Medtronic appears to be trying to do the right thing after the damage has been done. Medtronic deserves credit for this. But the problem with Medtronic and these other medical device companies selling defibrillators is that because defibrillators are so lucrative, in an effort to sell more product than the competition, companies rush out new defibrillators, supposedly technologically superior to older defibrillators, but with no proven history of safety and reliability.
Our law firm is not handling these cases.