The Medtronic Lead Recall - Not a Cause for Undue Alarm
The Sprint Fidelis lead, like all leads used with implantable defibrillators (ICDs), is a special electrical wire that goes from the ICD (which is usually implanted under the skin beneath the collarbone) to the heart. The lead allows the ICD to monitor the heart rhythm, and also carries a defibrillating shock from the ICD to the heart if a dangerous arrhythmia should occur. If the lead should fail, the ICD might not be able to detect or treat such an arrhythmia - and also, a failing lead could trigger painful inappropriate shocks from the ICD.
Medtronic is pulling the Sprint Fidelis lead, used in 235,000 patients, from the market because of a higher-than-expected failure rate. The Fidelis lead is reported to have a 2.3% failure rate (between 2 and 3 failures for every 100 leads used) within 30 months after implantation. This action will undoubtedly be labeled a recall by Medtronic and FDA.
Patients who have these leads will need to discuss their individual situations with their doctors. But during these discussions several things should be kept in mind.
First, the failure rate being reported so far for the Fidelis lead, while higher than expected, is not exraordinarily higher than for many ICD leads currently in use. Several ICD leads have failure rates approaching 2% at 3 years. Indeed, lead failure is by far the most common kind of "system failure" with ICDs.
Second, much better data regarding the Fidelis lead can be expected in a short period of time, as many of the 235,000 patients who have these leads are checked by their doctors. If the failure rate turns out to be higher than is now thought, it should not take a long time to find that out.
Third, patients should keep in mind that replacing the Fidelis lead would introduce two new risks: the risk of significant complications from replacement surgery (thought to be several percent), and the risk that the new lead would eventually fail (since all ICD leads carry a risk of failure which, at this point, may not be substantially lower than the risk that the Fidelis lead itself may fail).
The bottom line: lead failure is one of the inherent risks of ICD therapy. The information we have now indicates that failure rate with the Fidelis lead, while higher than expected, is not extraordinarily higher than expected. For most patients this will mean leaving the lead in place - at least for now - with careful monitoring of the lead over time, AND with careful monitoring of the overall risk with the Fidelis lead as the data becomes clearer.
Finally, if you have an ICD and this is the first you're hearing of lead failure being an inherent risk with ICD therapy, that's an issue you'll want to take up with your doctor.
Which model # are these leads used in? Is this lead used in all models of the ICD’s?
This is not the official word – second hand – but the affected models of the Fidelis lead appear to be 6930, 6931, 6948, and 6949. These can be used with virtually any ICD from any manufacturer.
Dr Fogoros statistics are WAY OFF !!!! The failure rate is much higher than is being reported. MDT’s failures are only based on confirmed returned leads. Less than half of the leads are returned. Fogoros must work for MDT !!!
The statistics I reported are those put forth by Medtronic and FDA, and are the best only statstics publicly available at this time. More data will be forthcoming soon as tens of thousands of patients are now having updated follow-ups. Further, if MDT in any way hid or creatively “massaged” their data, this will undoubtedly become known from aggressive investigations now being pursued by a cadre of nasty, aggressive lawyers, and by Congress (not to be redundant). If they hid something there will be hell to pay.
Unnecessarily replacing ICD leads from hundreds of thousands of patients at this time will result in unnecessary death or injury in thousands. The judicious course for overall patient safety is to continue following patients with these leads, and to continue carefully monitor the story as more data comes to light.
If epman has firm data to support his allegations that the lead failure rate is much higher than currently reported, he is morally obligated to make that information public NOW, so patients with these leads won’t have to wait for the process to unfold to learn the truth. If, on the other hand, he is speculating, then one can only hope that the panic he has chosen to promote will not cause too many patients to take precipitous, possibly harmful, action. [A devastating rejoinder to epman's gratuitous ad hominem attack has been mercifully withheld here.]
DrRich
My 30 yo male child has been shocked multiple time in the past 6 months, the last time being Sept 6 of this year (7 times). Each time the Medtronic rep appeared, interogated the device, engaged in idle chit-chat, and left, no explaination given. Friday he received a call from his physician with news that he would need both a ICD replacement (battery is near end of service life after just 14 months) and lead replacement (lead(s) is/are bad) but the nearest physician to do the replacement surgery is in LA and he is very busy. This news brings with it a whole new set of questions… Who pays all these bills.. You can bet the insurance company is not likely to pay for the replacement. What did Medtronics know and when did they know it? (sorry I had to throw that in) IMHO this is just the tip of the iceburg, but time will tell.
Jim K – My husband has been shocked 14 time unnecessarily in the past year, the last 13 times on Oct 14, just hours before the recall came out. We were fortunate in receiving very accurate information from the Medtronic tech. He was able to get taken care of at the University of Washington medcal center, with a new lead implanted last week. You’re right, what did Medtronics know and when? They say the chance of malfunction is small, but it is huge if you’re in the 2 to 3 percent. No one should have to suffer this.
I got a good 7 blasts in Aug. with no pre symptoms. Think my Dr.s offered up some recall info, no. Just the stupid letter I got today that sounds like one I should get from GM. I’m gona start carrying my razor knife and dykes.
My mom had a defibrillator/pacemaker implanted around nov. or dec. of 06. Two weeks later she felt a sharp pain while sleeping, when she went to the doctor about it they found that the lead had pulled out of her heart so they went back in and reinstalled the lead. she continued to feel worse and ended up retiring in april of 07. On one occassion she experienced vibrations like a pager going off in her chest, she went to the doctor and they just said if it does it again come back. she went into the hospital on july 19 for exhaustion for about 4 days. She continued to feel bad. Sometime around the end of august she went back to doctor because her blood pressure would be like 160/100 then 30 minutes later it would drop 60/50, according to the reading from here pacemaker she was told half her heart was beating fast and the other half wasn’t beating but by then it had corrected itself. On sept. 7th she went back into the hospital for breathing problems, she was put on a ventilator to help her breathe. Around the 11th they began turning the machine down because she was getting better and more able to breathe on her own. On sept. 13th about 2:30 am they called us all in because she coded, heart stopped and temp. went up to 107. We stayed a several hours and she seemed to be getting better so we went home. we got a call around 10:00am and was told to bring the family, we were informed sometime that night she had a heart attack and a stroke and that now only the machines were keeping her alive and we needed to make the decision of turning them off. We did and she passed at 2:23pm sept.13th.
She had a massive heart attack back in 98 and lived a pretty good life with just 23% of her heart muscle functioning. She started seeing a new doctor who put her on a medication that brought that percentage up to about 40% and as a back up they decided to install this new high tech defibrillator/pacemaker, her percentage of working heart muscle then dropped back down to the 20’s. Not until they decided to install this defibrillator did she begin to have more frequent problems and we feel that this defaulty lead may have contributed to her death.
I noticed that the lawyers are on this too and their sites seem to have morecomprehensive information than Medtronic or FDA.
> Medtronic Lead Recall Information Center and Nationwide Claims Filing Department has been opened at The Johnson Law Firm in order to provide patients with complete information on the Medtronic Sprint Fidelis Defibrillator Lead Recall. Patients can access the latest information on the Medtronic Lead Recall from the FDA and submit inquiries about claims for compensation to Medtronic Lead Recall Lawyers at the firm. >
Medtronic defibrillator leads have been recalled after the company identified at least five patient deaths in which a Medtronic Sprint Fidelis lead fractured and was a likely contributing factor to the death.
The recalled Medtronic defibrillator leads are the Sprint Fidelis Models: 6930, 6931, 6948, and 6949.
People with defibrillators should check the patient implant card that they received after their implant surgery to determine if they received one of the recalled leads. Patients should contact their physician if there is any uncertainty about being implanted with one of the recalled leads.
Patients who have had the Sprint Fidelis lead implanted should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.
If you or a loved one has been implanted with a Medtronic Sprint Fidelis Model 6930, 6931, 6948, or 6949 defibrillator lead then you should call us toll free now at 1-866-374-0338 because you may be entitled to medical monitoring and compensation from the manufacturer.
Larry – I noticed the same ; http://www.lawyersforclients.com/medtronic-defibrillator-leads
Father was shocked 246 times in a 3 hour period. DrRich, sorry if I am causing undue alarm but this was very “alarming” to our family.
Info:
Sorry to hear of your father’s dreadful experience.
I hope it’s obvious that I was saying most people with these Medtronic leads should remain calm for now, since the majority of these leads (it appears) will be fine, and since more information will be forthcoming. Equally obviously, anyone who actually has lead failure with any ICD lead (whether it’s this lead or not) ought to treat the situation with great alacrity (if not alarm).
DrRich
What is an appropriate response at the Emergency Room for a malfunctioning ICD which is delivering inappropriate shocks?
The response should be to shut off the ICD immediately, then placing the patient on a cardiac monitor (since the ICD is no longer functional) until the ICD problem is resolved. ERs should be ready to do this quickly – within a few minutes of arrival, no more shocks should occur. Otherwise, somebody is not doing his/her job.
Father was at ER in 30 minutes. Almost 2 more hours elapsed before the cardiologist “on call” arrived and shut it off. ER response was to take a chest x-ray and provided an injection of morphine. My father was screaming with each shock. If you work in an ER, please make sure they are equipped/authorized to handle this situation.
I had a [supposed] lead faiure with another ICD brand. My heart went into atrial fibrillation and stopped and the ICD failed to deliver the lifesaving shocks it was designed to provide. Luckily I was in a hospital elevator and quick reaction by hospital personnel saved my life. I was left with brain damage but have survived. The only symptom of a problem wa a drammatic decline in the lead impedence [which we later found out about] I wonder if this could be a symptom to watch for in the medtronic problem. Oh yeh i have the recalled medtronic leads inside me now..sucks heh.. Best of luck to all
Kirby
No one told us this, it’s been four months, just found out that Mom’s been implanted with a recalled model. How do I find out if the surgery was done AFTER the recall, and, if so, is that a normal practice??
The ICD gave a warning at the pacer clinic, Mom was told to “get in here right away” (”right away” being tomorrow at 3:30 ?!) so they can do some adjusting…
I’m her patient advocated and POA– how fired-up should I be about this?
Met the Meditronics rep today to get the so called “new programming” My alarms were already on so she really did nothing including not being able to answer my questions. When I mentioned the FDA recall, she was not even aware of it and had to place a call to Meditronics tech support to confirm what I was saying. They supposedly are sending me a magnet in the event the thing starts going off. Placing a magnet on it stops it from shocking. With Meditronics sending out un-informed techs like this lady, my concern with having one of the faulty leads increases even more. No doubt, they are in CYA mode and that’s about it. The lawyers are circling!
My mom had the medtronic fidelis lead 6949. When she first had it implanted in Jan 2006 we were told none of her leads were on recall at that time. In Oct 2007 Medtonic had a lead recall and one of her leads was on recall. SHe was called back into the office to check everything and was told all was fine. No one ever explained to her that one of her leads was on recall and the dangers of it. On 12/26 we all awoke to a blood-curling scream from my mom, who is 78 and weighs 98 lbs. She yelled her defibulator went off. Wihtin mins it went off again. We rushed to her ER where she was shocked an incredible 13 more times before they were able to get someone in to put a magnet in place to stop the shocks! It was horrible. She was admitted to Coronary ICU and we were told her lead had fractured. When the individual from medtronics came in to turn the device off, as soon as he removed the magnet, to put the device on that would turn the defibulator off she was shocked again! It was a horrifying experience for her and she is still terrified. THere has to be better steps in place to deal with this in ER than to wait until someone can show up to take action. Being in appropropiately once is inexcusable being shocked an amazing 13 times alone in ER iwith a total of over 16 times is absolutely beyond inexcusable. This recall has to be taken more seriously. No one should go through this… NO ONE. The pain an individual is put through is horrifying and the after effects of what it does to a person is hard to put into words. Every one who has these leads should be made aware of exactly what is in them and what can and does happen!
I forgot to add that prior to my mom’s episode with the shocks on Dec 26th 2007, she had to have a 2nd surgery to have the leads to her pacemaker and defibulator fixed. In addition to that during her horrifying experience with the 16+ shocks they also found the device had slipped in her chest and was out of place which could have happened duyring all the shocks – no one knows for sure. The bottom line is now her pacemaker is not working properly and her defibulator is turned off and she is faced with decisions on what to do and further surgery to correct this and has firmly stated she would rather die than have the defibulator turned back on and risk being shocked again. This is how bad it was for her after all the shocks! She’s simply terrified. It’s just plan outrageous this happened.
Medtronic’s website says “We have confirmed 665 chronic fractures in returned leads.” How many total returned leads were there? How many returned leads were exhibiting problems before being returned. I’m sure Medtronic has alot more information they are not disclosing.
Also, about the failures they state, “10% have occurred in the high voltage conductors.” From what they say, it does not appear there is any way to detect failures in the high voltage conductors until the ICD doesn’t deliver a life saving shock.
The other 90% of failures can cause unnecessary shocks. I think everyone with these leads should be given a magnet to turn them off if necessary.
My husband suffered about 15 or more shocks in one night but was admitted to the hospital after 4. It was determined the next morning that is was the lead, the 6049 Sidalis and was to be replaced the next day. Meanwhile after the 15-17 shocks they placed a very strong magnet over the pacemaker to stop them and heart monitor to make sure he would not need it. Each shock was stronger then the last. His surgery was more complicated and took about 4 hours ending with the pacemaker and 2 of 4 leads replaced. He is doing well but this should never have happened nor should it to anyone. He is restless now and fearful, can you blame him. Upon becoming aware of this Medtronics should have done the right thing. We don’t believe they did but tried to play it all down. That was wrong. IF you have the reported recalls please ask that they be taken care of as soon as possible. Telling us to wait and see what happens, is just not the right answer.
Does anyone know if additional pacemaker models have been recalled at this point.
My husband had complications with his pacemaker but a different model than the ones that are listed on the Medtronics website. His pacemaker was implanted Dec 06 for slow heart rate. He had rapid heart rate three weeks later. After the doctors performed an emergency cario-catherization it was determined that his heart was in “pristine” condition. The cause of the rapid heart rate was due to the pacemaker. They made some adjustments to the pacemaker and sent him home the next day. Many more serious complications followed.
On Oct. 31st/08, my Husband was shocked with a massive 30+ shocks from his Medtronic ICD with a Sprint Fidelis lead in place. I will never forget his screams and as an RN, I was helpless to do anything for him other than call 911. I can atest that the shocks from a fractured Fidelis lead, are inhumane. I have shocked many people in a hospital setting over the years and they were never like this. If my Husband had been driving a car, not only would he have killed himself, but others on the road as well. He was shocked an additional 12 times in the ambulance and another 3 in the ER before they got a magnet on board. Medtronic offered us $800 for a new lead and $2500 for proven out-of-pocket expenses. Our hospital bill for 2 surgeries will exceed $100,000 I’m sure….not to mention the irreversible psychological damage this experience has created for both my Husband and myself.
I’m not sure where this man got his info. My 47 yr old brother died from this ICD. It went off more than 200 times in one week. Yes I said one week. We had it put in because he needed just a few weeks “rest” before they would be able to do surgery. After the defibulator was placed he had 1 day before it started to go off. The doctors said that the shocks and its effects on his body damaged his heart so badly that he was no longer able to have surgery. He begged to have it turned off and no CPR performed. He died 8 days after it was placed. His death was a very torturous death. His cardiologist (not the surgeon) was crying over watching this. I pray no other family has to go through this.
It’s been three years since my brother passed away from this device. Some nights, I have Nightmares reliving the times it went off and we heard our brother scream in agony and pain.
Last Sunday, Feb 1, 2009 I was admitted to Mease Countryside Hospital in Clearwater, Florida after experiencing a prominent burning sensation near the device and severe lightheadedness. I followed the advice of the FDA website and wanted to contact my cardiologist. In as much as it was Sunday, I went to the ER ot the hospital. Preliminary test showed nothing, but they has me remain over night. Additional testing produced no more information and I was released. This problem scares the dickens out of me and scares my young 9-year old son, his mother, and all of my family. I’d just like some peace of mind. Stop me if I’m wrong. The device has to be removed to replace the battery. Instead of running the risk of removing the leads and implanting more, why can’t they just remove the device as though they were replacing the battery and just cap off the leads? I don’t want to die and certainly my family doesn’t want me to die. But I’d rather take my chances without the device rather than let it kill me. Has nayone tried having the device removed and the leads capped off? Must I become known by my first name at the ER? My doctors just ignore my requests and tell me about my excellent chances. Any advice?
Ihave one of those bad leads. Havent hadf any shocks yet. but I live in fear of it not working when I might need it most. I think of it morning, Noon, and Night They told me it would be to dangerous to replace. But it could kill me by not working when needed. I think we all should be composited for suffering everyday of our lives.They owe me for messing up my life with a piece that was suspose to sAVE MY LIVE BUT HAS TERRIFIED me everyday of my life.I’m only 57 and it was put in when I was 54. Doctors have almost killed me they had me on a medicine for dieabeteas that cause my heart attacks and then put in defibulATOR LEADS THAT ARE BAD. Thanks Doctors for ruining my Life.
Steven Landers
Well I just got the bad news last week. My leads are breaking, ( was implanted Jan. 04 before it was approved by FDA- was told that it would be shortly so I might as well get these new leads) and I also have the marquis defective device.My alarm was turned off, I don’t really know what this mean, is the defib also turned off. I’ve been stressed all week-end, I am supposed to see this specialist about lead extraction. I wasn’t given much explanation, I had to look on the internet this week end about this surgery, which is very dangerous. I already have another set of lead in the vein from a previous device, so, they cannot just add new leads, I’m no so sure I will have the extraction done,( the cure could be worse than the disease) I will look for other options. I am pretty upset though !!!
Wait and see if you die
It seems to me that Medtronics strategy to wait and see if any more
people die to poorly manufactured ICD leads is extremely cruel to the
medical field, the recipients of the leads and to our families.
I had one implanted in October of 2006. According to two of the
Medtronics Representatives, with whom I personally met, three years is
a good time to start worrying in earnest.
I simply want the device to be removed and the leads left in place but
capped. It seems like a simple solution. Eventually the device must be
removed to replace the batteries. Why not now? The doctors who saved
my life and either recommended or actually implanted the device are
left hanging out to dry by Medtronics. I’ve spoken to seven doctors
regarding the implant. One flatly denies that there is a problem, one,
the surgeon who actually did the implant stated that an accident
during surgery would cancel his insurance. One, my cardiologist, won’t
even address the problem. And four, all non-surgeons, say get the
thing out it’s DANGEROUS!
It’s difficult, not only anguishing through the problem, but fending
off sympathetic well-wishers who affectionately call to check on me.
Each time I get a call I end up having to defend the doctors, medical
devices in general, and Medtronics.
My nine year-old son feels that he can keep me alive if he physically
hangs on to me. It’s no way for a child to live. It’s heart wrenching.
The doctors, my friends and relatives, and my son are all good people.
They deserve better.
So where do we go from here? Nowhere. A federal court in Minnesota
with alleged personal ties to Medtronics has ruled that Medtonics
cannot be forced to correct the system because the FDA approved the
device. Meanwhile there has been some fifteen deaths reported (three
times greater than originally admitted by the company,) and countless
false “severe shocks” to the thousands who have been implanted with
the ICD.
Oh, by the way, Medtronics did adjust the software in the implanted
computer device using a magnet. I suspect that all it did was to make
the device less effective. Now I have a less effective defective
device threatening to kill me. Go figure.
My lead was implanted 02/07. I experienced a shock that very night in the hospital. I was told then that it did not register on their machine and it was in my head. I received 2 shockes in the first week after getting home and was told the same thing. My kids thought for sure I was loosing it, and I started to doubt myself. I got my Dr. Patient latter in October of o7. Now I find out that the FDA had 599 complaints one week before I was implanted with the “Time Bomb” Dr. Forogus says “No cause for alarm”: right. How would he like to have one of these “time bombs” in him, knowing it could go off at any time?
I was 44 when i had mine done now 2 years later having to go in and have 2 new lwads put in and the one that is not working taken out. Medtronic knew this 3 years prior to mine being put in and they still kept them on the market. I pray every one that has one that is on the recall list sues medtronic and wins
Jamerican , There are “phantom shocks” that seem real but do not show up when the device is interrogated. I have experienced both and can tell you that there is a diffence. You do not feel “drained” with the phantom shock. The real shock is dramatic to say the least. Good luck, Jon
My wife had an ICD with Sprint Fidelis leads(6931) implanted in August of 2007. She just had the old leads extracted and replaced with new leads on 10/09/2009. We have a monitoring device and it showed that her leads had fractured.Luckily she never experienced a shock but it was on our minds during the 2 hour drive to get to the hospital.One thing I am curious about is that all info that I read refers only to the 6949 leads and they never break out seperate data on the other recalled leads. Is it possible that the 6931 leads have a even higher failure rate.The even sadder problem is that we have no legal recourse to sue Medtronics even though anybody with half a brain can see that they knew they had a problem and chose to continue selling the device in order to meet Wall Street projections.It was strictly all about business and never about the safety of the unlucky people who were implanted.