Dr. Robert Hauser of the Minneapolis Heart Institute Foundation has said in today’s New England Journal of Medicine that he is not confident in the test guidelines for a next-generation heart defibrillator under development by Medtronic, Inc., Boston Scientific Corporation, and St. Jude Medical, Inc., reports the StarTribune.com.

Implantable cardioverter defibrillators—or ICDs—the device under question, represent a $5 million dollar market, with over 160,000 such devices implanted each year in the U.S., said the StarTribune.com, which explained that the devices are about the size of a stopwatch and work to stop sudden cardiac arrest by shocking the heart back into rhythm.  One ICD device runs about $30,000 said TwinCities.com. (more…)

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. (more…)

A new type of implantable defibrillator could become the latest target of computer hackers.  In recent years, over 100,000 patients in the US have been implanted with a defibrillator device that has helped to reduce medical visits.  The device and its technology enable patient information to be sent to a bedside monitor that then sends the data to a doctor.  Transmissions generally occur once daily.  Now, this relatively common defibrillator monitoring technology appears to be vulnerable to hacking and—worse—reprogramming that could stop the defibrillators from providing a lifesaving shock, according to research being released today.

Defibrillator transmissions sent to the bedside monitor are not encrypted, meaning that someone intercepting transmissions could retrieve data such as a patient’s birth date, medical ID, and Social Security number.  Researchers are concerned that as this technology is used in more devices—pacemakers, spinal cord stimulators, and hearing implants—and as radio ranges increase, patients’ data will be at greater risk.  “There will be more implanted devices and more wireless capabilities and transmissions over greater distances,” said Dr. William Maisel, a study authors and Harvard-affiliated director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston. (more…)

People with a Medtronic or St. Jude implantable defibrillators should know that  some of these defibrillators’ lead wires—specifically in the Medtronic Sprint Fidelis and St. Jude Riata lead wires—have fractured, perforated patient heart walls, or caused device failure.  In some cases, these malfunctions of the Medtronic Sprint Fidelis Lead and the St. Jude Riata Defibrillator Lead  have 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 it through the heart wall.

(more…)