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Heart Device Patients Often Unaware of Recalls
May 16, 2008 | Parker Waichman Alonso LLP
It seems that many patients who have been implanted with heart devices are not aware of recent recalls and do not understand the dangers they might face, this according to two new surveys. Although the surveys are small, they do indicate a lack of understanding among doctors and patients about heart disease and the devices used to treat it, said Dr. Bruce Wilkoff, director of cardiac and tachyarrhythmia devices at Cleveland Clinic Wilkoff, who is familiar with the surveys. "There are fundamental problems with even the physician's understanding of the situation and an appropriate focus on accurate information," Wilkoff added. One of the new surveys found that nearly one in five heart patients didn't know about recent recalls of their devices.Meanwhile, recent recalls of implanted defibrillators have forced some patients to have them removed. Spefically, defibrillator lead wires—especially those in the Medtronic Sprint Fidelis and St. Jude Riata devices—have fractured, perforated patient heart walls, or caused device failure. In some, these malfunctions led to additional cardiac procedures or complications and even death. Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops. A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator. When a defibrillator wire detaches or breaks, the device will fail leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made its way through the heart wall.
The findings are planned to be released at the Heart Rhythm Society's annual meeting in San Francisco and involved 61 randomly selected patients at the University of Maryland and the Baltimore VA Medical Center who were asked about recalls between October 2006 and April 2007. Eighteen percent didn't know about any pacemaker or defibrillator recall, about half learned about recalls through the media, 24 percent heard through their doctor, and over half said they'd be very worried if their device was recalled.
"We need to do a little better of a job and find better means of talking to our patients," said survey lead author Dr. Timm-Michael Dickfeld, director of electrophysiology at the Baltimore VA Medical Center. "They seem to like to have the physicians talk to them more, and explain these things more, and not leave it up to the media or the TV to inform them."
A second survey, conducted by doctors at the University of Oklahoma, asked 165 patients with a variety of heart devices whether they'd want them removed if there was a recall or safety advisory. Five percent reported they'd want the device removed immediately if there was a "recall" and 2.5 percent said they'd want it taken out if there was a "safety advisory."
Defective Medical Devices
