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Medtronic lead recall could have come earlier

Austin Kirk

Since the October 15th Medtronic recall for all models of their Sprint Fidelis defibrillator lead, more information has come to light about what Medtronic knew and when they knew it.  Despite information which was presented to company executives, Medtronic delayed the defibrillator lead recall for several months, allowing doctors to continue implanting the defective wires.

>>INFORMATION: Medtronic Lead Recall

An article in the Wall Street Journal earlier this week outlined steps that were taken by physicians at the Minneapolis Heart Institute, who identified problems with the Medtronic defibrillator lead at the beginning of this year.  Despite reports which indicated that the Sprint Fidelis lead was prone to early fractures, Medtronic did not issue a recall and at one point even attempted to shift the blame to the physicians who implant the devices.  Below is a timeline of the events leading up to the recent Medtronic recall, as reported by the Wall Street Journal.

MEDTRONIC RECALL TIMELINE

September 2004: The Medtronic Sprint Fidelis defibrillator lead was introduced as the thinnest wire available, with a diameter of 2.2 millimeters.  This made for easier insertion of the lead through the vein which connects the defibrillator to the heart.

January 2007: Doctors at the Minneapolis Heart Institute had two patients come into the clinic on successive days complaining that their heart defibrilator had delivered painful and unnecessary electrical shocks.  A subsequent search of hospital records by physicians at the Heart Institute found four similar cases, and it was determined that all six patients had a broken Medtronic Sprint Fidelis defibrillator lead.  The Minneapolis Heart Institute notified Medtronic about their concerns.

February 2007: A Medtronic vice president and engineer met with physicians from the Minneapolis Heart Institute and Dr. Robert Hauser, a physician who is well known for his role in the discovery of problems which led to the recall of over 200,000 Guidant defibrillators and pacemakers in 2005.  Althought Dr. Hauser and physicians from the Heart Institute told Medtronic that they had a serious lead problem on their hands, executives from the device manufacturer claimed that there was not enough evidence and suggested that doctor error when the leads were implanted could have caused the fractures.

March 21, 2007: Medtronic sent a letter to healthcare providers indicating that they had received reports of fractures from a limited number of physicians who implant the leads.  The letter attempted to reassure healthcare providers that the Medtronic lead was safe, and indicated that the problems may be caused by improper handling by the doctors during the implant procedure.

April 2007: Dr. Hauser published a report online in the medical journal Heart Rhythm, which concluded that the Medtronic lead “appears to be prone to early failure.”  The report was based on an analysis of a federal database and of records from a multi-hospital database.

July 19, 2007: Dr. Hauser and physicians from the Minneapolis Heart Institute met with Medtronic executives again to ask them to issue a defibrillator lead recall.  Medtronic indicated that they were not going to issue a recall, and that they were working to resolve the defibrillator lead problem which the company had already identified.

October 7, 2007: After reviewing the results of their own analysis of data collected since 2004 which indicated the Sprint Fidelis had a failure rate of approximately 2.3% during the first 30 months it was on the market, executives at Medtronic met and decided that the company would suspend sales of their popular leads.

October 15, 2007:  A press release was issued shortly after midnight announcing the Medtronic recall.  The company cited at least five deaths linked to their lead and acknowledged that their own analysis of data found that the failure rate was over two and a half times that of the older, thicker Medtronic lead, the Sprint Quattro.

MEDTRONIC LEAD RECALL LAWYERS

The lawyers at Saiontz & Kirk, P.A. are reviewing potential Medtronic recall lawsuits nationwide.  Any individuals who have the Medtronic Sprint Fidelis lead may be at risk for serious injury if the lead fractures or fails.  Claims are being reviewed for any heart patients who have had a defibrillator implanted since 2004.  To determine if you, a friend or family member may be eligible for a claim, request a free consultation.

26 Comments Add Your Comments

  1. Monika Barkley says:

    I am absolutely devastated by the news of the lead recall. I have the lead 6949 that was implanted in me at Duke Hospital August 13, 2007. I did some research and found through this article and the medtronic letter to physicians that they knew about the problem since March of 2007. I cannot believe they played God with my life until more data came in. I wrote Medtronic the statement below. I just cannot get over this because there is more of a chance of killing me if they try to remove so what, they’re going to “watch” me till the lead fractures……… then what?!!!

    “I am one of the “lucky” recipients of the 6949 lead in my ICD that was implanted August 13, 2007. I just read your letter to the physicians that Medtronic first voiced concern in March 2007 regarding the failure rate of the lead. WHY DID YOU NOT STOP IMPLANTING THIS LEAD WHEN THE FAILURE RATE WAS KNOWN TO YOU IN MARCH OF 2007 AND CONTINUE TO ALLOW THE PHYSICIANS TO USE THE LEAD UNTIL OCTOBER 15, 2007?!!! I am devastated that you played God with my life just to see if after a few more months of data to be received if the data still “lead” you to believe the failure rate was above what was accepted and you would do the right thing before the FDA forced you to make the recall. How dare you.”

  2. Jackie Blankenship says:

    I wonder why Medtronic has not notified of the same problems with the wires and eletrodes of the spinal cord stimulators? I resently had mine removed after the wires and electrodes broke in my neck and head!I now have problems I did not have before~

  3. tommie l cummins says:

    i had my device put in june 2006 ,at maury reginiol hospital in tennessee,i have been shot a lot of times with it ,who do you think you are ,god. my life is at hands i have a wife and daugther to take care of and all you people want is to get rich ,i can,t even get tenncare or medicare in this state ,and can,t work no more ,and now you,re people make it that much harder for me ,don,t you,re people care about god,s and what you,re doing to his people ,in the name of jesus have some faith.

  4. Kelley Gormley says:

    I don’t know for sure if my mom had one of these defected leads, but I wanted to share our story. In Sept 2006 my moms pacemaker lead came off and was shocking her. She had a heart attack shortly after that. They replaced her whole pacemaker and her leads. One year after Sept 2007 she was hospitalized again due to having blood around her heart. They later found out that two of her leads came off of her pacemaker. One punctured her heart and one punctured her lung. This seemed highly unusual to me that she had two pacemakers and both times the leads came off. She had to have major surgery to repair the holes. She died Oct 1, 2007. My mom was very young and we feel had this not happened she would still be with us.

  5. duane horner says:

    i have a recalled pacemaker and def model number 6949 right now my machine is off becuase i have the thin wire and is is broke so what do i do now can you tell me what to do i went through alot of pain getting this put in now it anit working now i have to decide what to do get it fixed or repaired or what i have 4 kids and 4 grand children who need me here with them and a lovely wife i got shocked 8 times with in one minute and rushed to the hospital next day got shocked 3 more time when i was seeing a heart doctor to see what was happening i was scared to death about this so can you tell me who is going to flip the bill this time again i suffered alot with the pain and im still having hurting pains all the time what if it happened to you you would be scared to death them shocks really hurt i never felt any thing like it before and now im scared to get shocked again by the machine that is suppose to help save my life not take my life my life dependeds on the machine that you made for me tell me what to do ive had my unit since dec 11 2005 luckily it aint killed me yet i thought iwas dying on oct 11 2007 at least my daughter was not home when it happened shes 7 but my wife had to go through the issues with me as with 2 other of my kids

  6. Danny F Haggard says:

    I to, had the model 6949 implanted 03/03/07. I recieved a letter from Medtronics notifying me of the recall and the minimal risk that it imposed on me. I just read the article,’Medtronic Lead Recall Could Have Come Earlier’.I am upset that Medtronics would not listen to Dr. Robert Hauser, after his role in the 2005 Guidant recall. This man has already proven his abilities, his expertise, and should have been taken serious immediantly. The recall could have taken place right then or shortly afterward.

    I am also very surprized that I have not heard from my physician who placed the device. He was notified of the problem less than three weeks after the surgery. Some thing could have been done right then, in an effort to take me out of harms way.

    Who will ensure that Americans have access to quality health care? Only by holding those responsible, accountable for their negligence, can peace of mind be restored to those who have been threatened by Medtronics’ reluctance to listen to the experts. The heart surgeons that have continued to use the faulty leads after being told of the dangers should also be held accountable. Good quality health care is expensive, even when you can afford it, you often do not recieve what you and your insurance company pay for. GET INVOLVED, IT CAN ONJLY HELP.

  7. Mac Chrupcala says:

    I hads my defib implanted in March of 06. In June of 06 it fired 30 times within an hour and fifteen min.I thought bthat it had fired fewer times until the device was interrogated and I was told the number.My lead was replaced with the explanation that it had disloged somehow causing it to misfire. i think now that it was a problem with the lead itself. To state that that incident freaked me out is an understatement!Now I hear that it could happen again and I am beside myself with both anger and apprenhension. I had the device implanted to try to extend my life for the benefit of my 5 year old daughter. Now i am considering deactivating the device and taking my chances. I have now heard that a few years down the road,I will have to deal with the defib trying to pace my heart against my own pacing as the battery begins to run down. This whole thing really stinks and Medtronic should be held responsible.

  8. STANLEY HESS says:

    i have two deep brain stimulaters in my brain in 2002 i’ve had the wires replaced on the left side on 10/02and battery replaced in 05.then they had to go back in and redo the wires and leads on both sides on feb. 10/06. then in 2/9/07 then replaced wires behide ear to battery pack in chest. i was get tingling in my toes and my left arm is always hurting. then in 10/3/07 had my left side totally redo again this time from in side the brain down to the chest and i’m going in for the right side to be down on 12/12/07. have you got any info on the deep brain stimulators as they sent the old wires and leads back to michican to see what the problems is the right side has been messed up for a year or more with shocking to the body when being reprogramed please keep me informed if you hear any problems i’m only 53 i realy don’t want to be schock to death thank you stan

  9. Austin Kirk says:

    Mr. Hess,

    At this time, I have not heard anything about problems with brain stimulator lead wires. This post is regarding lawsuits we are pursuing for Medtronic Sprint Fidelis leads, which are used to connect defibrillator leads to the heart. These leads are not approved for any other use.

    If you would like to review your circumstances further with our office, please request a free consultation or call our office at (800) 522-0102.

  10. I have a Medtronic SCS, implanted Oct 3, 2007 for RSD/CRPS II. I have complained of burning sensation at the implant site, and it also “jolts and Jerks” me to the floor. The Rep finally checked me on Jan 3, and I was informed I have a “leak” and “broken lead”. Are there any problems with model37701 restorePrime that you have heard of? My doctor is working on getting approval with my Ins to do a repair. I’m not sure I want to go through with the horror of being awake during surgery.

  11. Cheria Custard says:

    I had my ICD putin when I was 25, Feb 2005, with the defective lead. In June, I was riding in the car with a friend, laughing and I was shocked. The lead had broken. I had surgery to replace it(they used another defective lead costing $30,000) however the site got infected with stef and I was hopitalized for 12 days and almost died. Because of the infection they had to replace the whole device (also replaced with a defective lead – $180,000) and put it on the other side of my chest. I had to have at home care. Im 32 years old and I havent been the same since. The scars are horrible and now I dont heal very well. I have congestive heart failure and severe asthma. I am disable and just now got my medicare this Dec. because I was too young so the hospital is trying to get almost$250,000 from me.

    Im so angry that I still have to deal with this, that at any time it could break and I cant do anything about it.

  12. julie mennes says:

    my father went to the hospital on feb 1 08 for what we thought was a stroke, my dad had one of the recalled leads. he almost died more than once due to the infection from the lead site he has had kidney failure and had heart falure twice his legs are covered in sores from the infection he will be on medicine for the infection for 17 more weeks. no one should have to suffer such a slow murder!!!!!!!!!!!!!

  13. Medtronic Lead Problems - Software Update to Detect Medtronic Fractures | Legal News & Updates Blog - Saiontz, Kirk & Miles says:

    […] Medtronic lead lawyers at Saiontz, Kirk & Miles, P.A. represent individuals who received the Sprint Fidelis lead, […]

  14. I to have model 6949 I to had to stop work I am now disabled at 49 years old I have pain at the site have been to the hospital because sometimes my heart starts beating so fast that it feels as if it will come out of my chest It comes on so suddenly I have been to the hospital but they can never seem to find the problem I have children and grandchildren that need me can you imagine disabled at 49 years old and have to live on a fixed income.I hope they can live with thereselves and can sleep good at night.

  15. I have a spinal cord stimulator, implanted in 2003, removed in 2007 and Medtronic refused to replace the leads. I am looking for anyone who may have started a class action lawsuit against them for these leads as well.

  16. richard says:

    i have the 6949 15 shocks i like to know when did medtronics really know they had problems with these leads i think way before this money money money richard

  17. I was shocked 19 times in hour I want to know if I have a claim I was hospitalized for 3 months Then i had to take a drug from the bad nightmares and the day mares Do you think i have a case. How come the laywers are asking for more money when the patients are the ones that suffered from that 19 times in 1 hour almost 6 shock second they were 800 milliletrs per dose we should be getting a claim you think I would like to know more thanks Paul.2

  18. kathleen says:

    have a Medtronic SCS, implanted Oct 3, 2007 for RSD/CRPS II. I have complained of burning sensation at the implant site, and it also “jolts and Jerks” me to the floor. The Rep finally checked me on Jan 3, and I was informed I have a “leak” and “broken lead”. Are there any problems with model the model since they put it in 1999 lead breakage all the time frayed leads restore barrey that you have heard of? i beens having proplems with it and had 5 sugeys in the past 1 year in 2009 because the unit cause and infection in my back and it seems the doctors are afraid to say anything or to be wittness because it might hurt them or hospatals wee the work they are not afraid to take you money thow o hell no!!! they do not wnat to be wittenss because they are to close to the proplem.. they are the ones that have been there.. what if i saw somone get hit bye a car should i not come forward or should say i did not see anything and that how they are doing it now,, i am so mad i have gotten a lawer and when she talik to my doctor .. he said they were defected the paddles back in 2003 the paddles the same ones so you mean to tell be i have been walikng aroound with bad paddles for years??? and not known about it untill they knew about the leads that cause a proplem for 1 year.. what the hell i have pictures of this horrrow stoley and it seems the doctors that put it in they get paid everbody gets paid but us,, we pay with pain and suffeing I want to go through with the horror of being now my doctor does not wnat to be a wittens for this ……back peddle back peddle

  19. I HAVE HAD TWO MEDTRONIC DEVICES IN THREE YEARS BOTH HAVE FAILED AND HAD TO BE REMOVED. MY SURGEON PROVIDED ME WITH EXCELLENT CARE AS FAR AS THE INSTALLATION OF THE SCS#37713. I FEEL THAT HE TWO WAS MISLEAD AS FAR AS PRODUCT MEDTRONICS IS MARKETING FOR PAIN CONTROL. I AM LEFT WITH NO OTHER OPTIONS ONLY ORAL MEDS FOR LIFE. MEDTRONICS SHOULD BECOME A DEFENSE CONTRACTOR.

  20. With all the problems I’ve found in researching an SCS device, an extremely large number of articles about Medtronic seem to come up.

    I spoke with a rep. today who knew virtually nothing who sent me to another rep. who also knew very little… I WAS told the new leads are insulated with “Silicone Rubber”.

    Silicone breast implants lead to higher rates of lung cancer radical mastectomies, autoimmune problems, and many more health risks.

    In 2003, while the UK was putting silicone implants on their “highest risk category”, the FDA was considering an application by an implant manufacturer to lift all restrictions on the sale of silicone breast implants in this country.

    There are SO many restrictions with the current, US SCS units, I might as well NOT have the surgery and simply stay on pain medications with occasional spinal blocks.

    I certainly would not consider these devices to be even remotely “safe” or even close to it. Many people wind up in even more pain, with or without the devices if they’ve had an implant. Many have filed a multitude of lawsuits for having been implanted with defective devices,yet under apparently current law, medical device units are not regulated in ANY way, shape or form.

    If you are damaged or even killed by a defective device, you have no recourse as a result of Pres. Bush’s deregulating medical devices. This has these companies selling junk and they get away with literally IMHO murder because they are all about selling untested & unproven devices… ok, so a little testing *might* be done bythe FDA, but more than likely, it’s a rubber stamp.

    FAR too many new meds have been rubber stamped by the FDA as well, only to discover they are dangerous.

    I am not going to allow an implant of ANY device made by Medtronics, and wouldn’t wish one on my worst enemy.

    Perhaps if the entire board, investors and the design team were required to have their own devices implanted first, we might have a quality device on the market.

    Perhaps these companies should be sued for withholding quality devices that really work & be held accountable for fraudulent advertising?

    I am outraged!

  21. I have model 37713 for low back pain, surgery was Oct 08, now it feels like it is pushing out of my back, the pain is so intense I can not get a god night sleep, sit, stand, walk or do much of anything for an extended period of time. The pain from the device although it is off and I keep it charged. It feels like it is burning. I get a stronger burning feeling when I charge. I am so frustrated. Damn near suicidal. I am on more narcortics now than I have been since the accident in 98.

  22. I have had three spinal cord stimulators since 07 i keep haveing problems with this one , it will turn off for no reason at all or it will go higher then i have it setv, i have been reprogramed so many times and they say nothing is wrong and it must be electrial interferance or me moveing in a diffrent spot . No i dont think so its in my body i feel what its doing not them and there is something wrong one rep told me it was all in my head, what are we to do , because were damned if we do damned if we dont …..

  23. I had an Insignia I Plus SSIRO IS-1, 1194, 138089 put in 11/30/2006.
    On 3/15/12 I was taken to the emergency room with four broken
    leads. I am dependent upon my pacemaker 100%. The rep who
    came to my room later said this was unusual. I am questioning that
    now.

  24. I had the trail and two other of the spinal cord stimulators install my trail worked great so had first one installed .Had pain and just wasnt the same as trai after six months of tell dr and having medtronic reprogram dr ordered ex ray found lead was laying in my spine doing nothing so it was removed. Had second insatlled with paddle stile leads and had same proublems the pain was still there and got infection from surgery and after dr didnt listen infection was so bad battery was trying to come thru my skin so it was removed. I gave medtronics back all there stuff told them i dont want any more so back to trying pain meds that dont work eather.

  25. deborah says:

    Febuary 2012 I told my PM Dr that my Medtronic SCS wasn’t working on my right side. It took Jan.2013 for a Medtronic Rep. to verify what I had been telling my Dr and 3 Dr’s that gave me Epidural Steriod Injections that it wasn’t working. The Rep said my lead wires are broken on my right side.

  26. my husband had the stimulator model but in July 2002 and then replaced with 37713 because of so much pain ,swelling, infections , and leads not working only to find out the Dr forgot to change those leads and then wanted to go back in and try a new procedure making holes in the spinal cord and running new leads thru there ins.co questioned it because they had just paid for the new procedure . Medtronics Rep was caught in a lie by us he turned off the stimulator completely and made it look like it was broken while waiting for weeks leaving my husband in so much pain and swelling just to get the surgery redone which the Ins. co did not approve we over heard them talking about wanting to make more money on doing it all over and not mention about the leads broken..when we confronted them we were told no one had said the leads were broken and they didn’t remember talking about the leads??? since then my husband has been made out to look like he is just abusing his meds. and now needs help for his ” addiction” and not mentioning his pain from the stimulator and leads are killing him he has reg, visits to the the DR for his back but now the Dr. sends in his assistant and no mention of lead repair just giving him meds and appt for 2mos. . As of this date my Husband is suffering so much and has lost weight and appetite he has become very distant from everyone wont trust any drs on any surgerys anymore and is depressed .

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