Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its CareLink 2090 Programmer with Software Application SW034 version 8.3 and Encore 29901 Programmer with Software Application SW034 version 8.3 supporting the Claria MRI, Amplia MRI and Compia MRI Cardiac Resynchronization Defibrillators (CRT-Ds).
The manufacturer provides information regarding the potential for a one-time loss of diagnostic information due to a partial electrical reset that may occur for patients implanted with a Medtronic Claria MRI, Amplia MRI or Compia MRI CRT-D. Based on data available as of March 2020, the calculated occurrence rate of this one-time partial reset is approximately 2%. Device therapy and programmed settings are not affected by a partial electrical reset.
A patient with a Claria MRI, Amplia MRI, or Compia MRI may experience a partial electrical reset when the patient has their device interrogated with a programmer that has been updated to software application SW034 version 8.3, and it is the first interrogation with this new software.
The manufacturer's analysis identified that the 2% risk for a partial electric reset during the interrogation process is due to an uncommon scenario when a software update is installed simultaneously with routine critical memory scans. Should a reset occur, the clinician will be prompted to "Clear" the reset condition on the programmer (guidance to clear a partial reset is documented in the Instructions for Use for the devices). When the "Clear" option is selected, the programmer will automatically interrogate the device again, and will successfully write the software enhancement to the device memory. Importantly, 98% of download attempts will successfully complete without an electrical reset. Once the software update has been successfully installed into the device, the potential for a future partial reset due to this interaction no longer exists.
As documented in the Instructions for Use, a partial electrical reset will result in the loss of stored diagnostic information and episodes. The device longevity estimator will show an "initializing" status for the next seven days, and Recommended Replacement Time (RRT) status will continue to function as normal. Device programmed parameters, and all functions including detection and therapies are maintained. All Claria MRI, Amplia MRI and Compia MRI CRT-D devices are updated with the new software when interrogated for the first time by a programmer with software application SW034 version 8.3.
The manufacturer recommends continued routine management of patients. A one-time loss of stored device information may limit the physician's ability to assess their patient's clinical status – particularly when an audible alert, symptoms or VF shock delivery has been reported. Affected users should work with the manufacturer to identify data management options that may be available to their clinic.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 March 2020