St. Jude Riata Defibrillator Lead Wires Cause Bleeding Hearts
November 13th, 2007 amy
St. Jude Riata Defibrillator Lead Wires may detach and perforate the heart, says more than one major medical publication. Although it’s not entirely unusual for defibrillator leads to malfunction, these detachments and perforations are happening more than expected with the St. Jude Riata Defibrillator Leads. According to PACE, a publication for specialists who implant pacemakers and defibrillators, St. Jude and the FDA have received reports of perforations in four cases, and in one case, the tip of the lead was within 7 millimeters of the surface of the skin.
Since Medtronic stopped selling its popular lead, the Sprint Fidelis, the St. Jude Riata defibrillator leads have been in the spotlight. After a number Sprint Fidelis leads fractured inside patients’ bodies, the Food and Drug Administration recalled the lead, which has been linked to five deaths.
In an editorial accompanying the three case studies in PACE, Dr. Stephen Vlay, a cardiologist at Stony Brook University in New York, said “there is legitimate concern that the problem may be more than physician misadventure and that there may be an inherent design flaw in some of the models of the Riata lead.” Neither St. Jude nor the FDA has issued a recall of the device.
