Medical device manufacturer, Abbott (St. Jude Medical Cardiac Rhythm Management Division), has issued a medical device safety alert concerning its Ellipse Implantable Cardioverter Defibrillator (ICDs). The affected devices are identified as follows:
The manufacturer is notifying physicians that a small number of Ellipse ICDs may lose wireless radiofrequency (RF) communication.
In April 2018, the manufacturer released cybersecurity updates to the Merlin Patient Care System (PCS) Programmer and Merlin@home Transmitters. In a small subset of devices that received those updates patients can no longer be interrogated with wireless RF telemetry or monitored remotely. Investigation has determined that an RF authentication parameter limited to these devices is incompatible with the cybersecurity update.
According to the manufacturer, a total 256 devices are affected worldwide. Devices will continue to function normally, but remote monitoring and data transmission capabilities may be interrupted. There have been no reports of patient injury occurring as a result of the issue.
The manufacturer has developed a software patch for the Merlin PCS Programmer which restores wireless RF communication capability in affected devices. This solution does not present additional risk to patients and device explant is not required for the update. The solution will be available in an upcoming version of Merlin PCS Programmer software Model 3330 and the manufacturer will assist in updating programmer software and restoring wireless RF communication for these devices upon release.
The affected users are recommended working with the manufacturer's representative to help correct affected devices during the patient's next regularly scheduled visit following availability of the software.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 23 January 2020