Medtronic Lead Recall: More Problems on the Horizon
Medtronic Sprint Fidelis Defibrillator Lead wires may cause greater risk to Medtronic defibrillator patients than was originally thought when Medtronic first announced that it was, essentially, recalling the Sprint Fidelis leads. Sadly, and this really underscores where we are in this country with medical device safety, this news comes not from Medtronic, but from a report by a Deutsche Bank analyst named Tao Levy. The report indicates that the Medtronic Sprint Fidelis lead wires had poor sensing capability that may compromise communication between the leads and the defibrillator The Deutsche Bank report stated that potential concerns over the Medtronic Sprint defibrillator lead wires’ sensing and transmitting abilities “is something we have learned from our clinicians contacts, and we could see published in medical journals.”
So, apparently, Medtronic defibrillator lead wires not only have an unacceptable fracture rate, they also appear to have poor sensing capabilities, even if they do not fracture. The first news Medtronic defibrillator lead patients are hearing of this is not from the FDA or Medtronic, but from an investment bank analyzing the stock. Unbelievable. This should be Exhibit A in attacking the preemption defense. Exhibit B should be the Baxter heparin recall where contaminated heparin entered the market because the FDA confused which the names of the factories in China and believe it had already inspected the plant that make the active ingredient in heparin that supplied half of this life saving medication that we use in this country.
For lawyers not familiar with the litigation, a lead is a wire that is threaded through the blood vessels and connects to a defibrillator in the patient’s chest. The lead sends messages to the defibrillator that a patient’s heart rhythm is significantly abnormal. The defibrillator then returns a shock to the heart, through the leads, to shock the heart back into rhythm. If a defibrillator lead breaks, it can send a painful, and, of course, terrifying shock to the patient who may think he/she is dying. The fractured lead can also fail to give a needed shock to get the patient’s heart back in rhythm.
Unlike a pacemaker or defibrillator recall, these Medtronic leads cannot generally be recalled, because it can be risky and invasive surgery, particularly in those who have had the leads for some time. The FDA has suggested that it is generally not a good idea to replace a defective defibrillator lead. Common sense tells you that patients with the Medtronic defective defibrillator leads should be talking to their doctors about their options.













