Pacemaker Recall

Recently I wrote about recalls of implantable cardioverter-defibrillator (ICD) devices. Now an FDA inspection of Guidant's cardiac unit has led to their recall of 170,000 of their Insignia and Nexus pacemakers.

Pacemakers maintain a preset heart rate, most often in people whose heart rate is too slow. A pacemaker failure can cause patients to lose consciousness if the heart rate becomes too slow to pump adequate amounts of blood to the brain. One of the reported pacemaker failures was an intermittent or permanent loss of pacing without any warning. According to the company, nine hospitalizations, but no deaths, have resulted from pacemaker malfunctions.

If you have one of these types of pacemakers, there is a very small likelihood that it is defective since the company has thus far detected malfunctions in far less than 0.1% of the pacemakers they have tested. In addition, the failures affected only those devices shipped before March 2004.

The company has urged all patients with an Insignia or Nexus pacemaker to consult their doctors. However, you probably have no idea what type of pacemaker you have. I was told by the pacemaker staff at Johns Hopkins Hospital that they plan to send a letter to each patient who had one of these devices implanted at Hopkins. The letters will include instructions that will differ depending on the circumstances of individual patients. If you don't hear from the doctor or medical center that implanted your pacemaker within a few weeks, I recommend you give them a call.