Letter to the FDA urging an investigation of Medtronic defibrillator recall (HRG Publication #1826)
October 16, 2007
Andrew von Eschenbach, MD, Commissioner
Dear Dr. von Eschenbach:
Important live-saving facts seem to have been overlooked intentionally by both the FDA and Medtronic while the two were busy congratulating one another for doing a better job detecting and recalling the Medtronic Sprint Fidelis defibrillator lead than Guidant did in its product recall several years ago.
I urge you to conduct an immediate investigation concerning the following:
1. The total number of reports of injury associated with the Fidelis lead had climbed to 599 by Jan. 10 2007, including 204 cases in which patients received “inappropriate shocks.” (See Table and Figures 1 and 2 below.) The number of injury reports for the first two months of 2007 was 152, compared with 27 reports for the first two months of 2006. Some of this reflects the fact that the longer the defibrillator is implanted, the greater likelihood there is of a fracture, inappropriate shock or other medical problem with the lead. Why did the FDA, aware of the rapidly mounting number of injury reports, not force the company to recall defibrillators not yet implanted in the early part of this year? It is likely that the 1,030 injuries reported to the FDA after Jan. 10 included many patients with defibrillators implanted after this date. Had the recall and further implantations stopped then – instead of nine months later (this week) – many patients would have been spared the injuries and anxiety that occurred with these recent implantations.
Medtronic had been warned about the injuries. Dr. Robert Hauser of the Minneapolis Heart Institute says he contacted Medtronic in early February about the problem and published a review of the injury cases in late March. Indeed, The Heart Institute was so concerned about the risk that it ceased implantation of these defibrillators in January. (Conversation with Dr. Robert Hauser, October 16, 2007.)
2. As of January, Medtronic and the FDA already were aware of an escalating number of reports of injury in patients with this Fidelis lead. By Jan. 10, the cumulative number of injury reports associated with this lead reported to the FDA database was 599, including 204 cases in which patients got inappropriate electric shocks from their defective defibrillators. (See table below.) Despite this strong warning signal about these defective components, in the same month, January, Medtronic launched a massive direct-to-consumer advertising campaign to lure patients to seek advice from their doctors as to whether they could benefit from having a defibrillator implanted.
The $100 million Medtronic ad campaign, dubbed “What’s Inside,” including a commercial in which a soft voice promises viewers that inside the device, they’ll find "10,000 more kisses ... 200 more football wins," saying it will "always be there for you – close to your heart with the power to restart it in case of sudden cardiac arrest." The ad was clearly trying to frighten people, including many who would not be candidates for such devices. The goal? Turn that fear into a “let’s not take a chance” mentality that results in more consumers, inadequately informed by the ad, asking their doctors for the devices. Why did the FDA, aware of the rising toll of injuries from Medtronic defibrillators, not stop this advertising campaign?
In summary, the congratulatory comments by both the FDA and Medtronic have covered up the serious problems of the failure of an earlier recall and the FDA’s failure to stop Medtronic’s outrageous and irresponsible Medtronic direct-to-consumer ad campaign.
We look forward to a prompt response to these serious problems.
Sidney M. Wolfe, MD
Eunice Yu, Staff Researcher