Medical Device:

Guidant Implantable Pacemakers

In September 2005, Guidant Corp. informed physicians about two isolated failure modes for the INSIGNIA and NEXUS families of Guidant implantable pacemakers.

The failure modes may cause irregular or permanent loss of telemetry; appearance of a reset warning message; and/or sporadic or permanent loss of pacing output without warning. These failure modes can lead to serious health complications. Guidant has received several reports of syncope, bradycardia or heart block.