ST. PAUL, Minn.—St. Jude Medical Inc. said it is informing physicians about visual observations of externalized conductors on the silicone end of QuickSite and QuickFlex Left-Ventricular Leads, used to connect Cardiac Resynchronization Therapy devices to the heart.
The company said there have been no reports of patient injury or loss of therapy because of externalized conductors in these leads, but it said it will no longer sell these lead models.
But St. Jude Medical is making the incidence rate public so physicians have the most updated lead performance information with which to make important patient care decisions.
St. Jude Medical said it has confirmed 39 cases of externalized conductors, out of 171,000 QuickSite and QuickFlex leads sold worldwide, resulting in a current reported incidence rate of 0.023 percent. Because these leads continue to function normally, the company said it expects that this rate is under-reported. St. Jude Medical estimates that 3 to 4 percent of QuickSite and QuickFlex leads may exhibit externalized conductors.
The firm said it the overall safety and reliability of QuickSite and QuickFlex leads continues to be comparable to currently available CRT leads from other manufacturers.
This medical device advisory does not affect the company's continued sale of its newer QuickFlex Ã (micro) or Quartet LV leads.
A copy of the physician letter and additional information about these leads can be found on sjmprofessional.com.