Challenges with a Lead Recall

Not surprisingly, the inevitable investigations and litigation regarding the Sprint Fidelis lead situation has started:

(WSJ) In early signs of the pressure likely to come for Medtronic and the FDA, (Senator) Mr. (Chuck) Grassley, a Republican, last night sent letters to the company and the agency asking for more information about the leads. Separately, consumer group Public Citizen argued in a letter that the company and agency should have taken action sooner.

In addition, a group of plaintiffs attorneys, which has been a leader in major heart-device lawsuits, filed suits against Medtronic related to the Sprint Fidelis leads in federal court in Minneapolis and Puerto Rico, according to Hunter Shkolnik, one of the lawyers.

The investigations are likely to again focus attention on the FDA's oversight of medical devices, which are regulated under different standards than drugs. For instance, the Sprint Fidelis leads, which went on the U.S. market in 2004, weren't required to be tested in humans before they won FDA approval. Previous versions were tested in humans, but the Sprint Fidelis models weren't different enough from those earlier iterations to require human trials, the FDA said.

Now, looking back, things seem so obvious, don't they? It's all so easy, to detect these trends of lead fracture, isn't it? Well, maybe.

Then again, maybe not.

I thought it would be informative to check the FDA's MAUDE database for Medtronic's "safe" Sprint Quattro leads, and check on the number of deaths with that lead since 1/2005. And you know what? There are four deaths not related to infection. Hmm. 4 of 126,400 implants of Quattro leads (1 in 31,600) verses five of 268,000 implants of the "faulty" Sprint Fidelis (1 in 53,600). These data seem to support the Sprint Fidelis as less lethal than the Quattro. Could this be true? Admittedly, the FDA's MAUDE database is not the best place to evaluate such occurrences, but the point remains: verifying if the cause of death in an individual patient was actually caused by the lead itself is difficult - the circumstances of each death must be carefully evaluated and sometimes data are not available to ascertain the actual circumstances that caused death. How much time should a company get to do such an investigation before informing the public?

It does seem there are more fractures with the Sprint Fidelis than the earlier Sprint Quattro leads. But, according to Medtronic's 2007 Product Performance Report, the Quattro lead was also subject to fractures on occasion. So what number of lead fractures is tolerable? Zero of 126,400? One in 126,400? Twenty in 126,400? Two hundred in 126,400? When should the public be notified?

And if the leads fracture, don't we want to know why? What component was failing? What action is needed to correct the problem? Was the engineering of the lead responsible for the defect or the implant physician's technique? Does it matter? How long should a company be permitted to attempt to identify the root cause for a defect before the public is notified - 24 hours? A week? A month? 6 months? Should Medtronic have notified physician's first or the patients? Should Medtronic have notified the doctors before having an action plan established and a website developed to accompany the calls and questions?

These are all difficult questions to answer.

The Heart Rhythm Society has developed guidelines which begin to address and underscore the importance of many of these issues. Many of the actions taken with this recall have been in line with the initial draft of these proposals. Certainly, the information provided immediately to patients and physicians is much better with this recall than that we experienced in 2005 with earlier defibrillator recalls, but the challenges regarding patient notification and dealing with the clinical issues at hand remain.

I believe that the investigations ongoing and questions being asked are appropriate and worthwhile. The legal actions, too, may serve as an impetus for improvement of ICD systems. But in all of these dealings it is helpful to realize the complexity of the issues being discussed, and that in the end, it's the patients' interests that should matter most. After all, they're the ones dealing with the fallout.

-Wes