This advisory is the fifth in the past three months by the Guidant Corporation. This time the warning is for its top-selling pacemakers called Insignia or Nexus. A small number of the devices have failed to function which means they failed to speed up a slow heartbeat. Doctors say this can lead to light-headedness or even passing out.
The failures have not caused any deaths, but the Food and Drug Administration reports failures of the pacemaker Insignia as early as 2003. Because of this, doctors say the real issue may be when should companies report problems with medical products.
Dr. Christopher D'Haem of the Thoracic & Cardiovascular Institute says he expects this issue will be further debated and a recommendation will be made for all companies within the industry.
The FDA will likely classify this safety issue as a recall. Patients with the Guidant pacemakers in question, should call their cardiologists.
For more information on the safety advisory, visit:www.guidant.com