Following a two-week FDA inspection of its cardiac rhythm management manufacturing facility in St. Paul, MN, Guidant Corp. (Indianapolis) advised physicians and patients of two types of failures that have occurred in its Insignia and Nexus pacemaker models. The failures, although statistically rare, involved the sudden and intermittent or permanent loss of pacing ability, which resulted in serious heart-rhythm disturbances. No deaths were reported, but several patients experienced fainting, others required hospitalization for serious arrhythmias, and one had to be resuscitated following cardiac arrest.
Guidant reported that foreign material within a crystal timing component caused 36 failures out of 49,500 pacemaker units distributed worldwide, for a 0.073% rate of occurrence. Another type of failure occurred in 16 units of 341,000 shipped, for an even lower failure rate of 0.0047%. FDA classified Guidant's advisory about the former type of failure as a recall, whereas there was some confusion about the second instance, which appears to remain as a safety alert. It is believed that both advisories will eventually be classified as recalls.