Is there any good news?
Sort of. The good news is that the FDA has issed a recall of Guidant defibrillators and Guidant has agreed that this recall is necessary. The bad news is that there are over 100,000 units at risk in the United States alone.
But there have only recently been a larger number of "reported" failures because it was not clear until June 20, 2005 what was wrong with these units. And the only reason that it became public in June 2005 was that Guidant was concerned about the release of a truthful NY Times Report titled “Maker of Heart Device Kept Flaw From Doctors.”
Thus, only one day before the NY Times article, on May 23, 2005, Guidant sent doctors an “advisory” letter about the defibrillators. However, even then, Guidant refused to recall its units. So even during the next three weeks, there was less pressure on the public and the medical community to report adverse events.
Finally, in June and July, a series of recalls began. Now people are coming forward in larger numbers to report failures in their devices. In order to find out if your Guidant device is the subject of the recall, the best place to go is to Guidant's web site: Guidant defect lookup based on model and serial number.
The types of failures that are being reported for Guidant units fall into three categories. These are,
- Internal short circuit
- Memory error
- Magnetic switch
Although the FDA tracks failures, the fact that these defective units were known of and sold for three years shows that the FDA reporting system is "broken" and that changes are needed to make it easier to report and more comprehensive for adverse reports to become public knowledge. Further, it is widely accepted that the FDA’s voluntary reporting system reflects only a small percentage (as little as 10%) of the actual number of events. Thus, the number of adverse events may be far greater than Guidant has revealed.