Medtronic Unit Agrees to Consent DecreeApr 28, 2008 | Parker Waichman LLP
An agreement has been reached by a unit of Medtronic Inc. on a consent decree with the U.S. Food and Drug Administration (FDA) over quality system improvements for its external defibrillators. The agreement—which is subject to court approval—addresses concerns raised by the FDA during inspections and outlines actions Medtronic's Physio-Control subsidiary must take to resume unrestricted distribution of the portable electronic devices. Physio-control is a maker of external defibrillators,
Automated external defibrillators, or AEDs, are becoming more and more available in office buildings, schools, and other public venues for use by bystanders to help a person suffering from sudden cardiac arrest. Physio-Control stopped U.S. shipments in January 2007 due to quality problems. Medtronic said shipments to meet critical customer requirements and certain specified public health needs will continue; however, in September, Medtronic announced plans to eliminate about 200 jobs in the Physio-Control unit. The consent decree agreement requires court approval.
Meanwhile, last October, Medtronic announced it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators. According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or—in the worse case scenario—death. At least five deaths were linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.
The Sprint Fidelis lead has been used in implantable Medtronic defibrillators since 2004; most patients who received the devices since then have the faulty leads. Sprint Fidelis leads were used only in cardiac defibrillators—or complex devices with defibrillation capacity—not conventional pacemakers. Some patients with congestive heart failure use devices that included this defibrillation ability, and those were among the machines that use the Sprint Fidelis lead.
A company review of 30 months of data indicated the defibrillator lead had a continuing fracture problem. According to the company’s own estimates, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of Medtronic defibrillator implantation. Patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to replace the wire.
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. 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. Lead fracture can cause the device to beep, alerting the patient to seek immediate medical attention; however, the fracture can also cause a massive electrical shock resulting in extreme and sudden chest pain. Worse, the fracture can deplete the battery, rendering the defibrillator unable to deliver a necessary, life-saving shock to the heart. 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.