Pacemakers: Manufacturers sell devices they know are faulty
Pacemakers are being fitted to patients even when the manufacturer knows they are faulty, and may even be fatal.
A leading expert says manufacturers “repeatedly and knowingly” sell devices that are defective.
Dr William Maisel, director of the Medical Device Safety Institute in Boston, USA, says that the three major manufacturers of pacemakers have all at some time continued to sell their products after they have discovered they were defective, and sometimes lethally so.
His comments are made in the wake of the controversy surrounding the withdrawal of Medtronic’s Sprint Fidelis pacemaker, which had been approved in 2004 without a single human trial having taken place.
Since then, 268,000 devices have been fitted, but it was withdrawn last autumn after the manufacturer announced that it could fracture. After finally carrying out an in-depth study, the manufacturer discovered the fracture had caused five deaths, and had fractured in 665 cases.
(Source: New England Journal of Medicine, 2008; 358: 985-7).