The Medtronic Fidelis Pacemaker

The Fidelis lead was originally introduced as an improvement to the Quattro lead, which is thicker. Thinner leads are easier to thread for the surgeon, and were thought to be an improvement all around.However, it was found that the advantage to the Fidelis lead—its thin design—was contributing to hairline fractures that would impede the electrical impulses being delivered to the heart. The problem also proved to be a double-edged sword, given the dual role of the lead as a conduit for sending vital information from the heart to the Medtronic device. A fracture in the lead would garble the data, potentially causing the pacemaker or defibrillator to behave in an erratic fashion.Just as a pacemaker or defibrillation device fails in the delivery of life-saving shocks to the heart when needed, a device that delivers unnecessary shocks can pose an equal risk to the heart. At least one of the five deaths blamed on the fractured Fidelis lead occurred after a Medtronic device misfired so rapidly, it caused a heart attack.This has become an issue for thousands of Fidelis lead patients. In announcing the recall October 15th, Medtronic reported a failure rate of 2.3 per cent within 30 months of implantation. That translates to 5,000 patients out of the 235,000 who have received the Fidelis lead since they were first introduced.That's 5,000 individuals who might expect, statistically, that a fracture is on the horizon.But what of the other 230,000 patients? Statistically they should be fine. However, that's cold comfort. There are no lots drawn, or names pulled out of a hat, or patients rostered into either this group, or that. It leaves 230,000 patients wondering, constantly, if they will be one of the unlucky 5,000.
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