FDA reports that the number of implanted heart defibrillators that fail is increasing as they are becoming more and more complex.
A study conducted between 2000 and 2003 found that 4,225 defibrillators had failed during that period. The same amount was reported in the previous 10 years. The failure rate of the devices was significantly higher in the second half of the period studied than in the first half. FDA is reporting that malfunctioning defibrillators and pacemakers were directly responsible for 61 deaths between 1990 and 2002.
Most of the failures are a result of design changes that made the devices smaller while their computer memory was increased and their power maintained. Although the data and the results we received are quite disturbing, these devices remain to be lifesavers for several million people.
It is said in the end that there will be more careful monitoring of the problems, devices as well as the devices’ performance.