FDA reported to have reclassified a St Jude defibrillation device
On 22 January 2016 US medical device manufacturer St Jude Medical, Inc reported that the US Food and Drug Administration had reclassified a voluntary global field safety action relating to St Jude’s Optisure Dual Coil Defibrillation leads.
The defibrillation leads are now the subject of a Class 1 Advisory, the strictest form of Advisory issued by the US health regulator.
The St Jude Advisory relates to a group of 447 Optisure leads which may have been damaged during the manufacturing process.
The Optisure dual coil defibrillation leads are used in conjunction with implantable cardioverter defibrillators (ICDs) to monitor the heartbeat of patients with heart rhythm disorders. An ICD’s leads deliver electric currents to the heart to help restore normal rhythm when needed.
St Jude have advised doctors to monitor patients who were implanted with the relevant Optisure leads.