St. Jude Riata Problems Most Frequently Seen in Large Diameter Leads
New research suggests that the problems with recalled St. Jude Riata defibrillator leads, which were removed from the market last year amid reports that the small wires may poke through the insulation, appears to occur most often among those with a larger diameter.
St. Jude Medical released a summary of preliminary findings from its Riata Lead Evaluation Study (PDF) this week, which indicates that there is a 24 percent chance that the insulation on conductors in large diameter St. Jude Riata may fail, allowing the wire to become exposed in the patient’s body. That compares to only a 9.3% rate of the externalized conductor problems being found among small diameter St. Jude leads.
The study involved 724 patients at 20 locations in the U.S. and Canada. The finalized study will involve data from another 51 patients in Japan.
Did You Know?
Millions of Philips CPAP Machines Recalled
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.Learn More
St. Jude Riata Defibrillator Lead Problems
The St. Jude Riata, Riata ST, QuickSite and QuickFlex defibrillator leads have all been found to contain potential defects that may make the wires prone to penetrating through the insulation. This may cause patients to suffer dangerous and potentially life-threatening shocks or prevent the defibrillator from delivery a life-saving jolt when it is needed.
The leads are used with internal defibrillators that are implanted near a patient’s heart to monitor the heart rhythms and provide a life-saving electrical shocks if necessary. The leads connect the defibrillator to the heart and deliver the charge, but they are supposed to remain covered by insulation once implanted. However, in some cases it appears that the St. Jude lead wires have poked the insulation, leaving parts of the leads are bare and uncovered inside patients’ bodies.
Reports have suggested that the recalled leads pose a serious health concern for patients, as it is largely impractical for patients to have the small lead wires removed. This causes patients to require more frequent medical follow up examinations and the only thing they can do is hope that they do not experience any of the problems associated with the small wires that connect their implanted defibrillator to their heart.
"*" indicates required fields
More Top Stories
A new report indicates the U.S. Navy is struggling to process tens of thousands of Camp Lejeune water poisoning claims due to a lack of resources.
A group of plaintiffs have filed a motion with the U.S. JPML seeking consolidation of all Bard implanted port lawsuits before one judge for pretrial proceedings.
A Tepezza hearing loss lawsuit accuses the manufacturer of failing to provide adequate warning about the risks of the thyroid eye disease drug.