FDA has classified this pacemaker as a Class I recall. This means that the device could “seriously or fatally injure patients.”
There are about 1.7 million of these pacemakers that have been implanted since 1997. “The defects affect a small subset of Kappa and Sigma pacemakers, causing them to not respond or run out of batter power.”
Over 95 percent of doctors were notified about this problem and have confirmed their receipt of the Medtronic’s letter.
“Patients should seek medical attention immediately if they experience fainting or lightheadedness, the company said in a statement.”