Medtronics Lead Recall Lawyers File Class Action Lawsuit
Plaintiffs in the Medtronic defibrillator litigation are seeking class action certification against Medtronic 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 Medtronic 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.) Medtronic 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 a Medtronic defibrillator - 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 a defective Medtronic defibrillator 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 lawyers are representing patients with these Medtronic defibrillators with defective leads not only in Maryland but around the country. Fill out this brief form if you need additional information or would like us to review you case, or call us at 800-553-8082.
You can also click here for a question and answer of the issues in the defibrillator lead recall class action.
Comments
I'd like the ICD removed and the leads capped. Anyone know a doctor that would take an objective look at that idea?
Posted by: JJG | April 11, 2008 7:28 PM
Have I read that lawsuits are prohibited because the FDA had approved the device?? Mine failed too.
Posted by: Don Hannon | August 25, 2008 1:59 PM
My mother got a severe shock that was verified by the medtronic representative. She is 84yo. They had to remove the ICD and replace it with a pacemaker.It was very unsettling to her. This incident occurred in the last year. Is she a person who would (could) be included in this action?
Posted by: Stephen Stefani M.D. | December 27, 2008 8:13 PM
My husband have one of the defective ones and died in march- 13 -09 with no answers of what wen wrong i hope someone dous somenthing about this money wound bring him back:(
Posted by: silvia sargent | April 30, 2009 12:55 PM
My 15 yr old son has a bad lead. He has to go to hospital every 3mos instead of 6 mos, because of the bad lead;therefore we have more doctor bills. Does anyone know if we can get reimburse for the extra travel and office visits. If he didn't have a recall we would not have to go back so often. He has been shocked 9 times. He had an ICD storm and was shocked 8 times in 19 mins. He did need every shock and I'm very thankful for his ICD. They also seem to think that they will fracture in children more easily....does anyone know...
Posted by: anita | June 16, 2009 9:05 PM
3 weeks ago at 6 am, my ICD discharged for the first time.(a malfunction) A few minutes later it hit me hard 3 times then again and again. 13 times in 20 minutes. It scared us to pieces. The pain was more than anything I have ever dealt with. The 45 minutes ride to the hosp seemed forever afraid I would get hit again. Medtronic rep wouldn't tell me what happened, he just turned it off. Had the lead replaced, terrible pain from it and my daughter and I are shell shocked waiting for it to zap me again. Do I spend the rest of my life being afraid of this happening again?
Posted by: Vanessa Tower | July 20, 2009 7:01 PM
My father had one of the malfunction leads put in mid 2006, he was notified in October 2007, that he had one. On November 22, 2008, he was climbing a ladder in his kitchen to fix a light while my moma watched and the defibrillator went off the force through him through the air with so much force that he hit the ceramic floor which caused severe head trauma, he immediately went unconsious and died 5 hours later. I would like Medtronic to be held responsible - he had a check up on 10/22/8 everything was fine per his doctor. Something needs to be done to hold Medtronic responsible for these deaths. Money want bring my father back, but it will keep others from experiencing the same thing.
Posted by: Cindy Petit | November 10, 2009 8:08 PM
My son had the defib done in 2007. We was told there was only a small chance that his leads could be faulty.
The defib has an alarm on there, and if there was a problem with the lead the alarm would go off, which it did. So we had the lead & defib replaced. Ask fot the alarm to be activated. Also we had a machine which we downloaded every month so the hosp could check, ask for this as well. Medtronic are at fault, so they should be able to sort this out for you, they did for us.
Good luck
Posted by: Tina Keartland | August 18, 2010 7:49 AM