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Failure Rate of Medtronic Sprint Fidelis Lead Could Be Higher

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Minneapolis, MN: Patients with the Medtronic Fidelis Sprint lead, a medical device that connects to the heart and was expected to be effective in 95 percent of patients in spite of a recall two years ago, may be worse off than first thought. A new study suggests that three years after implantation the Sprint Fidelis lead is only expected to remain functional in 88 percent of patients.

Heart Surgery"The hazard of the Sprint Fidelis lead is increasing, while the failure rate of other defibrillator leads are low and stable," the two cardiologists who authored the study, wrote in the journal 'Heart Rhythm.' The report was published online yesterday.

This is not good news for the more than 235,000 patients who received the Sprint Fidelis lead before they were recalled. Not only is additional surgery required to replace the leads, replacement surgery can be hazardous to the patient, as removal of an existing lead carries significant risk. Removal could damage the heart, and according to a report in the New York Times some patients have died on the operating table, when a replacement procedure went wrong.

The Medtronic Sprint Fidelis lead was considered a breakthrough when first introduced, and surgeons were especially enthused. Much thinner than other leads on the market, the Sprint Fidelis was found to be much easer to work with on the operating table.

In the field, however, the leads have been found to be prone to fracturing. This can represent a huge impact for the patient, as the lead is what connects a defibrillator to the heart and acts as a lifeline for the patient, and a vital communications link with the heart. When a lead fractures, vital information from the heart may not reach the medical device. A heart in need of a life-sustaining impulse from the heart device may not get it. Worse, the reverse could be true. A heart in no danger, or without need for intervention is suddenly, and without warning at the receiving end of electric shocks from a defibrillator designed to keep a failing heart going.

Some patients have died.

Medtronic issued a study that seemed to suggest the Sprint Fidelis would continue to work effectively in 95 percent of patients, 3 years on.

However Drs. Robert G. Hauser of the Minneapolis Heart Institute, and David L. Hayes of the Mayo Clinic, have found in their updated study that the figure is closer to 88 percent based on combined data from 3000 patients from the two major hospitals the surgeons represent.

Medtronic remains of the view that their original forecasts are accurate. "It is important to note that data collected from center to center would be expected to vary," Medtronic said in a statement released yesterday. "We believe that our analyses are representative of overall Fidelis performance."

However, the two authors of this most recent study found that things looked a little differently. Drs. Hauser and Hayes reviewed the performance levels of all defibrillators implanted at their respective facilities over a 4-year period, from 2004 to 2008. Of about 3,000 leads in total, 848 were Fidelis leads, or about 28 percent.

Over the 4-year period the annual failure rate was 3.75 percent for the Sprint Fidelis leads, as compared to 0.6 percent failure rate for other leads.

Medtronic is standing by its original findings.

It should be noted that it was Dr. Hauser, of the Minneapolis Heart Institute, who effectively blew the whistle on the Sprint Fidelis lead after he raised concerns about fracturing leads in 2007. Dr. Hauser, in fact, started waving the red flag on the Sprint Fidelis lead several months before Medtronic triggered a recall of the device in late 2007.

By that time, Medtronic suggested that the failed Sprint Fidelis lead might have been implicated in five deaths.

The situation results in a conundrum for patients. With hundreds of thousands of patients still walking around with the recalled Sprint Fidelis lead in their body, every day is another day waiting for the other shoe to drop, for something to go wrong—much akin to a ticking time bomb in your chest. You'll never know when it will go off, if at all.

However, due to the risk of revision surgery, it's not like you can go and ask your surgeon for a replacement. The benefit must far outweigh the risk, before any surgeon would agree to replace a still-functioning Sprint Fidelis lead that may, or may not fail.

If a lead has failed, and it didn't kill you—the replacement surgery might.

Patients disheartened by a recent Supreme Court ruling that shielded the manufacturers of certain medical devices from product liability lawsuits, will find some degree of hope with the intention of some Congressional Democrats to introduce legislation that could nullify that decision.

After all, if you were given, and accepted a recalled medical device in good faith that has proven defective in some situations—and you may not be able to have it removed even if you wanted to—you should have some legal recourse available to you.

A qualified attorney will best be in a position to advice you on what your options are.

READER COMMENTS

Posted by
Scott McKay
on
New WOW update
X-ray on 1/6/2015 shows doctor FORGOT from 10/2013 deceive removal to remove 6 inch lead that is still inside me now torturously starting to protrude from my skin.
I have to get to emergency right now, BYE
Please help ASAP

Posted by
Scott McKay
on
I am looking for a product liability attorney to help me with a
RestoreSensor Model 37714 Medtronic Neurostimulation System that is
surgically implanted in my lower back 4/4/2012.
I have had 3 painful surgies to correct extreme pain caused by the
electrodes after the Medtronic Neurostimulation System LEADS broke.
This seems to be a regular problem that Medtronic's
has always known about but I was never told of these problems.
I have had a lower back fusion in 2007 and back pain since than, so the
Medtronic Neurostimulation System seemed to be an excellent choice.
The Medtronic Neurostimulation System did work great as to relive me of my
back pain and mostly to take less pain medicines such as Percocet 10/325.
This is now a major setback I feel that now has False promises, in that
Medtronic knows of these electrodes and leads causing major problems.

I BELIEVE my problem is not just the broken leads that a recent X-Ray
showed, but the main stimulation system itself failed and now sends an out
of control shock and pain impulse that I was not told could happen.
June 27th 2013 the Medtronic Neurostimulation System broke inside me to
where it shocked me painfully and uncontrollable until I struggled to reach
my remote control to turn it off. If I was not home at this time to reach
the remote control this would have been a torturous pain that I could not
have stopped until the device was turned off.

The Medtronic Neurostimulation System will now need to be surgically removed
permanently as I never want to be in this painful situation again.
I am disabled on Medicare at age 49 since 2008 from Colon Cancer and back
problems and cannot afford to have this painful operation.
I now feel that I have been taken advantage of for there own experiment as
to how these leads break.I had my Doctor remove the Medtronic implant Tuesday the Oct 15th 2013.
I believe these leads where moving around in me freely as much
as 6 inches or more from where they were originally placed, X rays would
show the severe pain this movement was causing me. The pain I am in at this
time has me wondering how well the surgery went. Did the doctor cut me too
much to take out the broken wires he was removing? I should mention here
that Dr. T is not a surgeon. However, thats the least of my concerns
right now.
As I mentioned, I have had and am still having major pain and suffering from
this implant and realize that this company was just using me. I saw a
segment on Good Morning America, Monday the 14th about how it can or can
not help you. Also I feel Medtronic representatives had no concern for me
and never offered any help or solutions which was very upsetting to me.
When I was in the waiting room the 15th, the Medtronic Rep walked into the
Doctors office and I had to address him. He would have just passed me by if
I hadn't addressed him. And he KNOWS me! After that initial greeting I
never saw the rep again. I presume he was there only to collect the
mechanism, which I felt I was entitled to keep in my possession.( I asked
for the mechanism and was told that I could not have it.) When I had the
operation, did I BUY the mechanism or did I just RENT it? Considering the
mechanism cost $20,000, I think I have a right to know! The fact that the
Medtronic people showed no concern and made me feel like a worthless Guinea
Pig leaves me with a feeling of hopelessness and helplessness as to my
future and quality of life.
I still do not have the funds or know how to pay for this operation. Doctor
T and I agreed that there would be no cost to me as I told him I could
not pay anything at anytime for this. He did cancel the initial bill for
$3,500. I would like to pursue this matter because I feel very strongly
that, in addition to helping me, other people should know what this company
is doing. No one else should ever have to go through the pain and suffering
that I have. The lack of concern and the riskiness of the machinery alone,
is enough, but the insufferable pain endured is unforgivable.
I am pleading with you to help in this cause.

Posted by
Lemuel
on
Tim and Wes:Thank you both for your comments on the data that were cipmoled. Tim, as you know, the data were obtained from PACES physicians. Thirteen of the 32 institutions reported NO fractures. I followed up in institutions where they had not sent in data and I suspected that they had a large population of patients with ICDs. All but one has submitted data. Tim, if you name an institution, I bet that we have them included!The data as they came in were consistent with fracture rates of the 6949 being about 2x as high as the FAILURE rate of the general population. The rate of fracture of the 6931 (we do not have data from Medtronic in their prospective study because they did not gather them) is tending towards being higher than the 6949 (p=0.07).The RPA data from Medtronic severely underestimates the number of fractures since it only takes into account the RETURNED leads. Any non-extracted leads or partially extracted leads were not included.The Prospective analysis only evaluated 6949 leads and DID NOT INCLUDE ANY PEDIATRIC INSTITUTIONS!!!Please note in appendix B the wide range of the 95% CI being as low as 94.2% survival at 30 months. At our request, Medtronic did an analysis of their data for survival of the Fidelis leads of patients below age 21 compared to the Quattro based on their RPA (by their admission, an UNDERESTIMATE of the true rate). The 6949 lead had a survival rate of 96.2% while the Quattro had a survival rate of 99.4%. Again, this is survival rate, not fracture rate. Their data are consistent with ours. The 95% CI for our data for fracture in all leads was 3.86-7.83%.Medtronic realizes that they have a larger problem with these leads in younger people.I did not go to the reporters of the WSJ. They obtained some of our preliminary data from someone within our community. I spoke with them to make sure that they had accurate data.The reporters, in my opinion, presented the data fairly. I can assure you that there will be more issues to come.Wes: It was great speaking to you this evening. I will call you tomorrow about the patient you transferred over.Wayne

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