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Medtronic Sprint Fidelis, St. Jude Riata Defibrillator Lead Wires Endanger Patients
Nov 19, 2007 | Parker Waichman Alonso LLP
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.
There is growing speculation that the thin design of Sprint Fidelis and Riata lead wires are causing the perforation and fracturing problems seen recently due to too-thin diameter models. The Food and Drug Administration is currently investigating the link between defibrillator lead wire diameter and safety and performance issues.
Although one woman exhibited no problems, doctors discovered her perforation from a St. Jude Riata Lead in a routine visit five weeks after her defibrillator implant. The device had not been delivering a sufficient jolt. St. Jude Riata defibrillator lead wires have been detaching from patients’ hearts and perforating patients’ heart walls, with one patient’s wire moving from inside the heart to within millimeters of the patient's skin. While such malfunctions can happen with any defibrillator lead, evidence is emerging that this sort of detachment and perforation is occurring more frequently than expected with the St. Jude leads. Massachusetts General Hospital reported a perforation rate of 3.8 percent, or five out of 130, for the St. Jude Riata Defibrillator Lead. Doctors from New York Hospital Queens reported that of 59 St. Jude Riata Defibrillator Lead implants, five perforated; the hospital no longer uses the defective leads. St. Jude Riata insists its internal monitoring indicates their lead is no more likely to perforate patients’ hearts than other leads and their lead has a minimal 0.33% perforation rate; however, it is possible that their data is incomplete since many physicians are not reporting perforation incidents. St. Jude Riata has not issued a recall.
Medtronic—the nation’s largest maker of implanted heart devices—acknowledged five patient deaths linked to breaks in its Sprint Fidelis Lead wires and issued a recall last month. Medtronic has used the defective Sprint Fidelis Leads since 2004 on more than a quarter of a million patients. The Medtonic Sprint Fidelis Lead wires are prone to fracture and can cause device malfunctions such as unnecessarily jolting the heart or failing to deliver life-saving defibrillation. The leads’ failure rate is considered significant.
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