The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Fortify ST Implantable cardioverter defibrillator (ICD) models [CD1235-40, CD1235-40Q, CD2235-40 and CD2235-40Q], manufactured by St Jude Medical.
The Merlin PCS Programmer software Model 3330 versions 14.2.2, 16.2.1 and 17.2.1.1 provide new features for St. Jude Medical pacemakers, ICDs and CRT-Ds, including an option to enhance the ST diagnostic features in St. Jude Medical Fortify ST ICD models CD1235-40, CD1235-40Q, CD2235-40 and CD2235-40Q via a device software upgrade. During a device software upgrade, implanted devices are temporarily placed into the back-up pacing (BVVI) and back-up defibrillation only (BDFO) mode. The back-up mode parameter settings will be in effect for the two minute upgrade process. Once the upgrade successfully completes, the device will revert to the previously programmed parameter settings. The safety alert is being provided to ensure that the operation of these devices during backup operation is clearly understood. Depending on the individual patient, this temporary change in parameter values could make the device susceptible to over-sensing and potentially deliver high voltage therapy during the upgrade procedure.
In order to prevent the potential for inappropriate therapy during the software upgrade process, the manufacturer advises users to consider programming the "Tachy Therapy Enabled/Disabled" function to Disabled prior to proceeding with the software upgrade. It is imperative to re-interrogate the device and program the "Tachy Therapy Enabled/Disabled" function to Enabled after the upgrade has been successfully completed. As with any device evaluation and programming, ECG monitoring and availability of back up external defibrillation equipment is recommended during the entire software upgrade process.
According to the local supplier, the affected products were distributed in Hong Kong.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON261823
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 April 2013