Medtronics Lead Recall Lawyers File Class Action Lawsuit

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.

  • JJG

    I’d like the ICD removed and the leads capped. Anyone know a doctor that would take an objective look at that idea?

  • Don Hannon

    Have I read that lawsuits are prohibited because the FDA had approved the device?? Mine failed too.

  • Stephen Stefani M.D.

    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?

  • silvia sargent

    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:(

  • anita

    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…

  • Vanessa Tower

    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?



  • Cindy Petit

    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.

  • Tina Keartland

    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

  • Karen W. Brown

    The heart specialist encouraged the implant of the defective device for my father in April 2006. I was sitting in the room with my father when the device went off. The force was so strong that I felt and heard movement across the room. I could not believe the force was that strong. The unit would go off for no reason. We found out that the lead wire was defective but my father was to weak to operate. My father died in June 2009. No amount of money can bring my father back. His quality of life deteriorated after the implant. Medtronic and the doctors that encourage the use of defective products should be held accountable.

  • Loren Mortensen

    On Aug 10, 2011 my wife received 60 shocks from her Fidelis lead. We were not aware that a class action lawsuit had already been settled by Medtronic. We were not aware of any alrm system in the defibrilator. She had to have the entire system replaced. Do we have any rights or compensation for damages and cost of replacement?

  • Phil Swanson

    I have been shocked numerous times
    in the past.Medtronics came to visit me in the hospital last time I had problems an I have not had any problems since.The rep from medtronics said he was adjusting my Icd but now I’m not sure did he just turn it off?I was
    being checked regularly now they have stopped.

  • John C Zonneveld Jr

    I have a lead that is bad, and they are to replace it. I have not sufferred any shocks but I have to go through another surgery. Do I have any rights or compensation for damages and cost of replacement.

  • I had a device with a bad lead installed in 2007. I heard via a news broadcast prior to the insertion that bad leads were causing injury and deaths. I am troubled with the thought that the implant Dr. did not bother to have the leads checked before installing them in my chest. Medtronic should be required to pay realistic damages to anyone who had to live in fear that a lead could fracture and harm, or kill them. The “Class Action” Law suit is a joke! In my opinion there was no litigation process, it seems more like a Medtronic “Dictator” process took place, with them TELLING the laid back Lawyers “this is what we’re paying, take it or leave it” Money rules..

  • Al.Howard, Sr

    John, I had a bad lead also. The pace/difb was replaced and the bad wire was “capped”. They offered a $1000.00 gross settlement providing there are no Medical liens attached to my claim. Of course the Lawyer will get 1/3 plus of the $1000.00. before I get a dime! I turned the “take it or leave it” offer down, good luck..

  • I stand corrected. I recieved a call today informing me of the fact that the questionable Lead was not replaced and/or “Capped” during my Pac/Difib Replacement procedure! Yep, the “BAD” Lead is still alive and continues to threaten my demise!

  • gary

    what is the status on the money settlement

  • Richard Burrell

    I received several shocks because I had Sprint Fedlis (Medtronic) Model 6945. I initially slapped the remote control out of my roommates hand thinking the remote control was causing the shocks, I was wrong. The pain involved in a shock is excruciating to say the very least. I could see my chest expanding and the flash of light you get when it happens is insane. It happened several times before a nurse on my island had googled it and put a large magnet over my device. I had and entirely new device and new leads put in made by guidant. I just recently reached EOL on the guidant and had the new device put in two weeks ago. No problems with the second leads they left them in. Is your firm still representing new clients??? if so please contact me ASAP. Thank you

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