Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its A710 Intellis Software Application [Affected version: Software version 1.3.80].
The manufacturer is voluntarily issuing an urgent medical device correction notification to request the customer to update the Model A710 Intellis Software Application, used with the CT900 Clinician Tablet Programmer, to version 1.3.130.
The manufacturer has received fourteen reports between January 2020 and 24 November 2020 where users encountered the validation error followed by a system error on the CT900 Clinician Programmer affected software version indicating that the stimulator programming update could not be completed.
The affected software version may not reset invalid memory correctly which can result in the inability to update therapy settings, causing changes to the Patient Programmer display, provide access to unapproved functions of the Patient Programmer, and/or loss of therapy. This system error is not a frequent event and the occurrence rate has been reported as lower than 1 in 10,000.
Affected users are advised to download the latest update to the A710 Intellis Software Application, version 1.3.130, to the CT900 Clinician Programmer. They can be found on the Digital Connectivity page of the manufacturer website or at https://www.medtronic.com/softwareupdate or user can contact the manufacturer for assistance.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 23 December 2020