FDA Issues Class 1 Advisory for Optisure Leads
The FDA has issued a Class 1 advisory for St. Jude Medical's voluntary global field safety action concerning Optisure dual coil defibrillation leads, the company announced.
The Class 1 advisory involves 447 Optisure leads, which may have been damaged during a manufacturing step. Of that number, 278 leads were distributed in the U.S.
The company has received no reports of lead malfunction or patient injury. Physicians with patients affected by this advisory have been notified, the company said.
An investigation revealed a variation in the process to remove excess medical adhesive used in the assembly of the superior vena cava shock coil could result in cuts to the insulation of the lead, potentially causing an electrical malfunction.
However, the company says there is a low probability for this problem and that any associated risks can be prevented with device reprogramming. — Jonathon Shacat