St Jude Medical—QuickFlex and QuickSite Left Ventricular CRT Bipolar Leads: ETFE-Coated Cable Conductors May Become Externalized

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In April 3, 2012, Medical Device Advisory letters submitted by ECRI Institute member hospitals, St Jude Medical states that it has received 39 reports of the leads below exhibiting externalized ethylene/tetrafluoroethylene (ETFE)-coated cable conductors as a result of abrasion of the silicone insulation in the distal portion of the leads. St Jude Medical also states that it has received no reports of electrical dysfunctions, serious injury, or death associated with this problem; however, the firm estimates that between 3 and 4% of the above leads may exhibit this problem. Unipolar QuickSite, QuickFlex μ, and Quartet leads (model 1056K, model 1258T, and model 1458Q, respectively) are not affected by this problem.

If one of the above leads were to experience an externalized conductor, the ETFE coating on the cable is designed to provide adequate dielectric strength for the lead to continue to function normally without the silicone covering. The above leads also provide for multiple alternative programmable pacing configurations. Although no electrical dysfunction attributed to external conductors has been observed to date, St Jude Medical states that if all of these redundancies were to fail, the inability of the lead to pace may affect biventricular pacing, potentially resulting in exacerbation of heart failure. For further information regarding the root cause and clinical aspect of...