In St. Jude Riata Defibrillator Unit Significantly Worse Than Medtronic’s Quattro I discussed the growing evidence of St. Jude Medical, Inc.’s (“SJM”) Riata defibrillator lead failure. Michael Minton of Joelton, Tennessee is one of 79,000 U.S. patients who currently have the Riata defibrillator implanted in their chest.
After viewing an X-ray image of his defibrillator—which he said looked like an appliance wire stripped of its insulation—Mr. Minton has decided to undergo a surgical procedure to remove the defibrillator. The removal surgery itself carries a significant risk of complication, including:
- tearing of heart tissue
- chance that wiring may be left inside veins
Mr. Minton is not alone. Doctors at Vanderbilt University Medical Center have used X-rays to identify 29 defibrillator leads with noticeable insulation problems; one-third of the leads were subsequently removed, beginning with defibrillators that were simultaneously malfunctioning.
A participating Vanderbilt doctor commented: “I don’t see anything good that can happen from leaving all these leads in.” These sentiments were echoed by Dr. Epstein of Brigham and Women’s Hospital, who noted that “[p]eople don’t like that time-bomb thing.” Other leading cardiovascular entities, such as the Heart Rhythm Society, have not taken a formal position on extraction and await further data.
SJM has long recommended against removing the defibrillator prior to malfunction due to the attendant risks. Nevertheless, Mr. Minton and other Riata patients have decided that the danger posed by SJM’s faulty product outweighs the risks of another surgery