St. Jude Medical Issues Lead Wire Advisory Letter

St. Jude Medical Inc. is voluntarily telling doctors about a potential problem with its left ventricular lead wires. According to the company, its QuickSite and QuickFlex LV lead wires used to connect cardiac resynchronization therapy (CRT) devices to the heart occasionally have become exposed on their silicone ends. St. Jude only has confirmed 39 cases of exposure out of 171,000 leads sold globally thus far, which works out to 0.023 percent.

The risk posed by exposed leads is that they may cause an electrical short in the implanted CRT device—there have, however, been no reports of adverse effects or injury caused by lead exposure. St. Jude’s letter to physicians merely is a conservative measure intended to inform medical practitioners of possible risks associated with the leads. The St. Paul, Minn.-based company recommends that physicians “continue to monitor their patient’s implanted system at regularly scheduled intervals with attention paid to diagnostic information related to LV pacing performance.”

This communication comes after Heart Rhythm Journal published a study in March examining the St. Jude recall of its Riata and Riata ST leads last year. Those leads were the direct cause of 22 deaths, according to the Journal, though St. Jude maintains that the number actually is 20.

St. Jude’s QuickFlex µ and Quartet Optim leads are not included in this advisory. These leads are insulated with the specially patented material Optim, while the Quicksite and QuickFlex LV leads are coated with conventional silicone.

St. Jude’s products are targeted to the cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation markets.