Medtronic’s Sprint to the marketplace

-InjuryBoard.com

08/29/2008- Medtronic’s rapid move into the market place with the Sprint Fidelis defibrillator lead contrasts with the dead slow recall of a medical device that defies a physical recall.

First let’s take a look at a picture of the device. The diameter of the Sprint Fidelis lead (6930, 6931, 6948 and 6949 models) is only 2.1 millimeters, a nickel’s thickness. When Medtronic introduced the Sprint Fidelis in 2004, it already had a larger diameter lead on the market called the Sprint Quatro (6944 model) with a larger diameter of 2.8 mm. Medtronic developed the smaller diameter Sprint Fidelis for ease of implantation.

Public health physician, William H. Maisel, who has consulted for the FDA authored an article entitled, “Semper Fidelis – Consumer Protection for Patients with implanted medical devices.” The Maisel article appears in The New England Journal of Medicine (March 6, 2008), and it is very balanced and revealing expose on Medtronic’s Sprint Fidelis lead.

In his article, Dr. Maisel pointed out that the FDA approved the Medtronic Sprint Fidelis “on the basis of bench testing but no human clinical data.” From 2004 through 2007 90% of implanted Medtronic defibrillators contained the Sprint Fidelis lead. However, after 38 months on the US market and 268,000 implantations, Medtronic recalled the Sprint Fidelis because the smaller diameter lead was fracturing more often than the Sprint Quatro

Here are a few simple graphs that depict what Medtronics knew was happening: The first graph shows e model 6947 Sprint Quatro predecessor lead with the larger diameter. Notice how the thick blue line shows failures over a nearly six year period with a slow occurrence of failures. The second graph depicts the failure rate for the Sprint Fidelis model 6931, one of the recalled models.

Notice that after less than a year, system failures were looking a lot like the Quatro failures after 5 years. Medtronics did send a letter to physicians updating them about a plan for device enhancements. However, Medtronic sent a letter to consumers, assuring them that “the chance there will be a problem with your Sprint Fidelis lead remains small." Knowing the information at hand, Medtronics could have voluntarily recalled the Sprint Fidelis leads in May rather than October.

During discovery of these failures, the FDA was placing great weight on Medtronic’s limited PMA data. Medtronic and th FDA decided to act nearly a year after physicians began seeing patients who were complaining about strange occurrences. Patients were complaining of being electrically shocked with high voltage a multiple number of times a minute, due to a malfunction with the Sprint Fidelis leads. Sometime the leads did not transmit signals and failed to function as required. The linked FDA video provides some information about the recall.

The main problem with this particular recall is that very few of the defective leads are being returned to the manufacturer for further study. In most cases, removing those leads might cause even more devastating injury to the patient. However a reversion to older technology may permit safe removal of some leads.

However, lack of a plan for safe removal of an implanted device may itself be termed a design defect, and it may explain why Medtronic chose to bench test the Sprint Fidelis and not to test the device in humans before seeking approval. However, this story about the Sprint Fidelis would not be complete without the following information.

Although patients implanted with the Sprint Fidelis had been showing up at hospital clinics since January 2007. complaining of severe pain and other symptoms of malfunction, Medtronic reassured doctors that all was well within limits, and blamed the problems on physician technique. Yet, the safety gap between the Fidelis and the older Quatro was increasing. This discrepancy led Henry Waxman (D-CA) to write a letter to FDA Commissioner Andrew von Eschenbach, requesting a comprehensive timeline of the recall and an overview on how the FDA approved supplemental parts for medical devices.

Congressman Waxman sent a letter to the FDA requesting more information about why the FDA did not require Medtronic to submit clinical trial data to support the safety and effectiveness of the Sprint Fidelis leads. Mr. Waxman also wanted to know whether the FDA would approve a defibrillator lead under a distinct premarket approval (PMA) process (i.e., a brand new application needing new studies) or as a supplement to a PMA for another device (i.e., claiming substantial equivalence for a device already on the market). Mr. Waxman also cited 37 supplements listed for the Medtronic Transvene Lead System PMA, the same PMA under which the FDA gave approval for the Sprint Fidelis lead.

In addition, Medtronic became the focus of a further congressional investigation. It seems that rushing a medical device to market to beat the competition is sometimes not enough to do the job. Evidently, kickbacks are necessary. After Medtronic had already spent 40 million dollars to settle kickback charges, Senator Charles Grassley (R-IA) asked Medtronic to explain post settlement allegations that the company had lured doctors with “sham consulting agreements, sham royalty agreements and lavish trips to desirable locations.”

If these allegations are true, wouldn’t it have been a better choice for Medtronic to have spent all of those 40 million dollars in kickback money on research and comprehensive clinical testing, before bringing the Sprint Fidelis to market?