Recall of defibrillator leads
Once again, the activism of Dr. Robert G. Hauser, a cardiologist at the Minneapolis Heart Institute, has improved safety for cardiac patients worldwide. Dr. Hauser published an analysis earlier this year that suggested problems with the leads in Medtronic defibrillators, and unnecessary, painful firings of the defibrillator. Dr. Hauser's research had previously resulted in the recall of malfunctioning defibrillators manufactured by Guidant Corp. Dr. Hauser brought his findings to Medtronic's attention earlier this year, but was told that there was insufficient data to support a recall or reach any conclusion. Data from other clinical trials has since corroborated Hauser's concerns and resulted in the decision to halt sales.
It turns out that the small wire leads on Medtronic defibrillators were showing a pattern of stress failures that had already resulted in five documented deaths by the time Dr. Hauser's research was published. Medtronic has now begun urging doctors to use a different, larger implanted lead and indicated a willingness to pay a limited amount ($800.00) to re-implant fractured leads in uninsured patients. Medtronic is unwilling to voluntarily replace defective leads which have not yet fractured, however.
Approximately a quarter million patients have the small diameter "Fidelis" lead implanted, and Medtronic estimates that 4 to 5 thousand of these patients will experience a lead fracture in the next 30 months. It is far more dangerous to replace these leads than it is to replace a defibrillator. The leads Medtronic was using prior to 2004 are larger in diameter and have not demonstrated a history of failure. The two other manufacturers of defibrillators claim that they have not experienced similar difficulties, due to the use of different materials or larger diameter leads.
According to FDA records, one patient death was linked to a lead failure in August of 2006. Two additional deaths were identified in FDA records in January and March of 2007. A Medtronic spokesman confirmed that it had identified two additional deaths since March.
While Medtronic acted more quickly than Guidant responded to similar problems several years ago, it still responded more slowly than it should have. The defibrillator market is a six billion dollar business and each implant costs $30,000.00 or more. Medtronic, with 12 billion dollars in sales in 2006, has 55 percent of the defibrillator market and according to the New York Times, the device is its "biggest" product. Needless to say, it would delay an announcement that would disrupt its sales and upend its stock price for as long as possible.
The New York Times quoted Dr. William Maisel, a heart device expert at Beth Israel Deaconess Medical Center in Boston, who pointed out that the general reluctance to stop sale of a lucrative device is compounded in the medical device field because manufacturers have not created monitoring methods of anticipating or recognizing potential failures and device manufacturers are consistently scrambling to "catch up" with safety developments.
Thirty-five year old Stephanie Martinson, a speech pathologist in Palo Alto, California, puts a human face on this problem: her Fidelis lead gave her 26 painful shocks in a single hour before the lead was removed in March of this year. It was replaced, with another Fidelis lead, unfortunately, in May of 2007. This was almost a year after the first FDA-recognized death, two months after Medtronic sent a warning notice to doctors, but four months before the product was recalled. Sleep well with your new lead in place, Stephanie.