The FDA has escalated St. Jude Medical's voluntary global field safety action related to the company’s Optisure Dual Coil Defibrillation Leads, to a Class 1 Advisory, because they may have been damaged during a manufacturing step, according to a press release.
The advisory relates to a limited and well-defined group of 447 Optisure leads, 278 of which were distributed in the U.S.
An investigation revealed a variation in the process to remove excess medical adhesive used in the assembly of the superior vena cava shock coil, in a limited and well-defined group of Optisure leads, could result in cuts to the insulation of the lead.
Depending on device programming and the depth of the inadvertent cut to the insulation, compromise of lead insulation can potentially lead to an electrical malfunction wherein the defibrillator cannot deliver appropriate high voltage therapy.
Optisure dual coil defibrillation leads are used in conjunction with implantable cardioverter defibrillators, which monitor the heartbeat of patients suffering from heart rhythm disorders.
To date, the company has received no reports of lead malfunction or patient injury related to this issue.