Failure Rate of Guidant Defibrillators Doubled
"Medical device maker Guidant (GDT) said Monday that the failure rate from a faulty hermetic seal in some of its recalled pacemakers has increased from summer projections. The company, based in Indianapolis, told doctors that 145 cases have been reported of 16,000 pacemakers that remain implanted in patients' chests, raising the failure rate from July's range of 0.17 to 0.51 to a new range of 0.31 to 0.88%. Guidant also acknowledged another batch of 54,000 pacemakers might have a similar problem, after a manufacturing mix-up included faulty components with those that worked correctly. Of that group, about 19,300 pacemakers remain implanted."
Read the full article in USA Today here.