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.
Dear Sir,
I have a question in regards to this finding. Is this a new problem or as after some investigation via medtronics website, is this one more of the issues that the company has yet to reveal? My father has this particular lead implanted and the only thing done for him was to turn on a alert that will go off at a specific time each day. Has there been any information on if they can detect this issue or is it another wait and see thing?
This information comes not from Medtronic or the FDA, it comes from a Deutsche Bank analyst. It is a sad commentary when we have investment banks giving us a heads up about defects in lead wires that are in the chests of a quarter of a million people. I suppose he has contacts in the medical community and someone gave him a heads-up about medical articles on the horizon. I don't think he would speculate about future medical journal articles unless he had some sort of inside track.
I have an implanted defibrillator with one of the recalled leads. Model #694965ID w/ a s/n of LFJ050210V On January 29th, 2008 I was shocked 29 times in about an hour long period. I have since had an ablation. Medtronics interrogated the pacemaker and says that all of those shocks were justified (I have a bit of a hard time believing that) Recently I began having extreme problems with my Atrial Fibrillation and it almost feels like before I had the pacer (like it is not delivering the proper therapy) I went to the Cardiologist and my pacer was interrogated and they see significantly numbers of episodes and the durations are extremely long (as long as 25 hours) but once again they say the lead is fine. To say I am a little nervous is an understatement, but now my Cardiologist wants to do an AV Node ablation which will leave me completely dependant on the pacer. Needless to say this really raises my stress level because there is no guarantee that even though it is not fractured now; that it won?t fracture in the future, so I am trying to cover my basis and see how I should proceed. You can contact me via the email address below or DOCDONCA@verizon.net My Home # is 562-804-7057