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.

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.