Medical device manufacturer, St. Jude Medical, initiated a field safety corrective action concerning the QuickSite® and QuickFlex® Left Ventricular CRT Leads [Models 1056T, 1058T, 1156T and 1158T].
According to the manufacturer, the affected devices are designed for use in combination with a compatible pulse generator to provide long-term stimulation and sensing of the left ventricle via the great cardiac vein or one of its tributaries.
The manufacturer had found 39 confirmed cases of externalized conductor. It was estimated that 3-4% of QuickSite® and QuickFlex® leads may exhibit the anomaly. There were no reports of death or serious injury associated with externalized conductor.
According to the manufacturer, if externalization of the cable conductor were to occur, the ETFE coating on the cables is designed to provide adequate dielectric strength for the lead to continue to function normally without the silicone covering. The system also provides for multiple alternative pacing configurations that can be programmed, if needed. Although no electrical dysfunction attributable to these external conductors has been observed to date, in the case that all of these redundancies were to fail, the inability of the LV CRT lead to pace could affect biventricular pacing and result in exacerbation of heart failure.
The manufacturer recommended physicians to continue to monitor their patient's implanted system at regularly scheduled intervals with attention paid to diagnostic information related to LV pacing performance, in particular LV lead impedance and capture thresholds. In addition, programming of alerts that monitor lead impedance changes outside of the nominal range and enabling the patient notifier should be considered.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.