Friday, March 13, 2009

Medtronic Updates Doctors on Sprint Fidelis Defibrillator Lead

In anticipation of an upcoming New York Times article to run this weekend, I just received my 'dear doctor' letter from Medtronic updating the status of their advisory Sprint Fidelis defibrillator lead. Reportedly, the NYT article will highlight a recently reported study published online before print from the medical journal Heart Rhythm that describes a higher-than anticipated failure rate from the lead. These data are in contrast to other published data assembled in Medtronic's 'Dear Doctor' letter.

While there is probably no larger cardiac device concern for electrophysiologists and their affected patients, Medtronic's disclosure with patient management recommendations based on Hauser's data and others before the release of the upcoming article in the New York Times is appreciated and should assist patients and doctors as they discuss their treatment options. Importantly, Medtronic points out:
"The FDA’s MAUDE database currently has 107 Medical Device Reports (MDRs) that include allegations that the Fidelis lead may have caused or contributed to a patient death. Most of these MDRs were not initiated by medical professionals; the majority were initiated by family members or attorneys with minimal supporting data. Medtronic’s Independent Physician Quality Panel has reviewed 89 of the 107 reports. It is not possible to determine cause of death with certainty. The Panel has identified 13 patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.

The Panel noted that four of the 13 deaths were associated with lead extraction, highlighting the risks associated with that procedure. With the exception of the appearance of deaths associated with lead extraction, no new or unexpected trends have been observed."
So we'll see that the news article says, but one thing's for sure...

...Monday should be interesting.


NYT article 13 Mar 2009: "Medtronic Links Device for Heart to 13 Deaths"

Dr. Wes: Medtronic's Sprint Fidelis Performance Lead Update - May 13, 2008
Dr. Wes: Challenges With a Lead Recall - Oct 17, 2007
Dr. Wes: More on Medtronics Sprint Fidelis Advisory - Oct 15, 2007


Anonymous said...

I'm up on top of that fence. I fear the effect of litigation that takes technology away from those who really need it. I also fear for myself, with a set of SF leads in my chect that could kill me. With proper testing this could have been avoided. Time for congress to do what millions of electorate hired them for. Decide, finally, why life should trump profit every time.

Jay said...

It would be interesting to do a quick "back of the envelope" calculation to see how many lives have been lost by patients so fearful of ICD malfunction that they choose not to put them in at all.

We all have watched the market growth for ICDs decline over the last few years. I've counseled many patients reluctant to have ICDs implanted due to fear of malfunction. It's a strange illogical discussion as you remind the patient that by not having a device at all, it's as if they had a device with a 100% failure rate.

Even if you only attribute a very small portion of the market decline to the bad PR from all this inflated attention from the media and lawyers, the number of people who have died from reluctance to be implanted would dwarf the number who actually died from device malfunction.

How do we get this message out?

Those who inflate fear are responsible for actual patient deaths.

There is a big difference between this situation and Vioxx. The arthritis community is not underserved, and no one dies because they choose not to take the newest NSAID.

Don't get me wrong. I'm as concerned about device malfunction as anyone should be. I actually put very few Fidelis leads in because I was concerned that they might be subject to fracture. There are better ways, though, to save lives than what's being done now.



DrWes said...


Couldn't agree more.

It is frustrating to see the doubt, the questioning, the concern over implantable defibrillators, but I think the days of idealism in medicine are long over. Patients have more information at their disposal than ever before. Maybe, just maybe, that's a good thing since these devices do present real physical and economic challenges different than drugs. Still, we have a responsibility to discuss the absolute and relative risks (AND well as benefits!) of these devices to the best of our ability and let the patient ultimately decide.

The bigger problem I see is that of referring DOCTORS whose minds are equally swayed by these reports without knowing the current reliability of these devices.

Their education, ultimately, is up to us.

Best I can offer.


Anonymous said...

Very interesting and very crazy time. Thanks for posting this. I have or had a lead that gave me more then 100 shocks in a row. It is sad to see everything that is going down. I am being anonymous since I don't want my name getting out, and not quite sure who Dr. Wes is. But if you have any questions from a first hand experience leave a comment and I will check back in. Also if you aware of any online discussion groups on this topics please let me know.