MHRA issues field safety notice on St Jude Medical Optisure™ Dual Coil Defibrillation Lead
St Jude Medical has issued an “Important Medical Device Advisory” letter to medical practitioners regarding certain models of St Jude Medical Optisure™ Dual Coil Defibrillation Leads. The affected leads were launched globally in March 2014.
The UK’s regulatory body the MHRA, has published the advisory note as a field safety notice.
St Jude states that the insulation of a number of models may have been affected during the manufacturing process, potentially compromising their performance.
If an affected lead is connected to a device there is potential for the damaged lead to result in loss of defibrillation therapy during attempted shock delivery.
Medical staff are being urged to return all leads with the affected model numbers to be returned immediately to St Jude Medical.
The affected models are: LDA220Q/52; LDA220Q/58; LDA220Q/65; and LDP220Q/58
447 leads are reported to have been affected worldwide, 164 of which have been implanted or are on hospital inventories outside the USA. No numbers for the UK are available at this stage.
The defibrillation lead is a critical part of an implantable cardioverter defibrillator (ICD) which sends an electrical shock to the heart to start it pumping again. They are often recommended as preventative treatment for people at risk of a cardiac arrest. The defibrillation lead provides pacing and sensing, and delivers therapy to the heart.
The medical device team at Leigh Day is currently investigating a number of claims on behalf of individuals who claim to have experienced serious health problems following the implantation of heart devices.
Patients concerned about their defibrillator leads or ICD devices should contact their doctors as soon as possible.