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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
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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