Medtronic Fidelis Pacemaker

Medtronic's Fidelis pacemaker was different from other pacemakers most notably because of its lead. The lead on this pacemaker was thinner than usual, which was intentional in the pacemaker's design, due to the greater ease surgeons would have routing and connecting it to the heart. However, what made the pacemaker easier to set up in patients introduced a gigantic problem for the pacemaker's operation.

The thinner lead was much more prone to fracturing. This, obviously, would disrupt electrical impulses being sent to a malfunctioning heart. It would also scramble signals from the heart back to the pacemaker, which is just as dangerous; one paient with a Fidelis pacemaker died because the pacemaker, receiving jumbled data through a fractured lead, misfired very rapidly based on the incorrect data, causing a heart attack. The pacemaker was recalled on October 15th, 2007; Medtronic announced upon recalling their device that there had been a 2.3% failure rate in paients within the first 30 months receiving the device. Though this may seem like a small percentage, there are around 235,000 people with the Fidelis pacemaker. This means that roughly 5,000 patients can expect to have fractures in the leads of their pacemakers.

Replacing leads is no easy or inexpensive task: many complications can arise from removing leads from hearts, and the operation costs $12,500. Medtronic now offers replacement leads for free, and up to $800 towards the cost of the operation, but only upon reccomendation on lead removal by a doctor; not all people are in good enough condition for such an operation. And even with $800 towards the operation, patients deemed suitable to replacement may still be barely able or unable to afford the $11,700.