The fallout from the problems with Medtronic's Fidelis defibrillation leads continues, and in unexpected ways. For instance, consider one 48-year-old man who, earlier this week, underwent 90-minute operation at a New Jersey hospital to have the device removed and replaced. This occurred,
The New York Times writes, two months after Medtronic warned docs and nearly 250,000 patients that the lead, which some call a wire, connecting their electronic defibrillators to their hearts might break.
But as the paper points out, thousands of other patients with failing hearts face some key questions - should they have the potentially faulty lead removed or leave it in place and hope it does not fail? And if they do have it extracted, how will they pay for it? The device maker will only contribute toward a replacement lead and $800 toward each procedure, which can cost $12,500 or more. So far insurers are deciding whether to cover operations on a case-by-case basis, unless a lead has already fractured. “This has been a nightmare,†the Morristown Memorial Hospital patient tells the paper. The problems became widely known on Oct. 15, when Medtronic reported its Fidelis lead was fracturing at a higher rate than the Quattro, a thicker lead it had been rapidly displacing since being introduced in 2004, the Times writes. Data suggested that 2.3 percent of Fidelis implants fracture within 30 months, meaning more than 5,000 likely malfunctions among the estimated 235,000 patients with the leads. Medtronic said the Fidelis fractures, which could prevent the defibrillator from firing when needed, had been linked in reports to five deaths and caused numerous unnecessary shocks.
Most Fidelis users will not end up needing such an operation, the Times notes. And so far, the business impact has been less that Medtronic had originally forecast. Last month, the company — which gets close to 40 percent of its revenue from defibrillators, heart pacemakers and related products — said overall sales had risen 2 percent in the past year to $3.12 billion in its fiscal second quarter ending Oct. 26. Nonetheless, there are reverberations, such as shareholder lawsuits.
And the number of patients with potentially faulty leads has made this the most widespread problem yet involving a heart device. The episode has drawn renewed scrutiny to the way medical devices are approved and regulated in this country. The episode has led to investigations in both houses of Congress. “It seems like a good time to figure out where we are in regulating leads and what we can do better,†Dan Schultz, who heads the FDA's center for devices and radiological health, tells the paper.
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