A frayed Durata lead wire could cause an ICD to malfunction, either by sending unnecessary shocks to the heart, or failing to deliver such shocks when they are needed.
New York, New York (PRWEB) June 14, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective medical devices, is warning patients of new safety concerns associated with St. Jude Medical Inc.'s "Durata" lead wire, which is used to conduct electricity between an implantable cardioverter defibrillator and the heart. According to a report from Bloomberg News, the U.S. Food & Drug Administration (FDA) has received a report of a Durata lead wire fraying in one patient. A frayed defibrillator lead wire may result in an externalized conductor, which could cause an ICD to malfunction, either by sending unnecessary shocks to the heart, or failing to deliver such shocks when they are needed. Either scenario could result in painful injury, and potentially death. [bloomberg.com/news/2012-06-13/st-jude-s-durata-linked-to-case-of-externalized-wire.html]
According to Bloomberg, the Durata lead wire was the replacement for St. Jude's Riata line of defibrillator leads. St. Jude stopped selling Riata leads in December 2010 and officially recalled them in December 2011, amid reports that the Riata wires could break through their insulation coating and fail to work properly. St. Jude said that the Durata's new insulation coating, called Optim, would prevent a similar fraying defect. [fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284390.htm]
According to Bloomberg, an unnamed physician has reported that fraying was observed in a patient with a Durata lead in April, 2012. "Non invasive programmed stimulation of ICD, revealed undersensing of ventricular fibrillation after induction," the report to the FDA stated. "Fluoroscopy of lead revealed externalization of conductors. The externalization was confirmed at lead extraction. The externalization was adjacent to the distal coil of the lead." No other details were given. [accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2561677]
According to Bloomberg, this marks the first time fraying has been reported with a Durata lead. However, the report is raising concerns that the Durata lead may very well suffer from the same defects that prompted the Riata lead recall.
Parker Waichman is offering free legal consultations to any ICD patient who may have experienced a device malfunction due to a defective Durata lead wire. Please contact their office by visiting the firm's Durata lead injury page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800-LAW-INFO (1-800-529-4636).
For more information regarding Durata lead malfunctions and Parker Waichman LLP, please visit http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney