Potential for Partial Reset During Programmer Interrogation
Claria MRI, Amplia MRI, Compia MRI and CRT-Ds
Original Date of Communication:
CareLink™ 2090 Programmer with Software Application SW034 versions 8.3 and 8.4
CareLink™ 29901 Programmer with Software Application SW034 versions 8.3 and 8.4
STATUS UPDATE - NOVEMBER 2021
Medtronic has identified two versions of software that are susceptible to the one-time partial reset during programming interrogation – software applications SW034 version 8.3 and version 8.4. As documented in the original communication (March 2020), the risk for a partial reset on first interrogation with a programmer is approximately 2%. As of November 8, 2021, there are 448 complaints received due to this issue and zero (0) adverse events reported.
This advisory has been addressed through release of new software to correct for the issue. Software application SW034 version 8.5 (or higher) must be installed on Model 2090 and Encore programmers to correct for this issue. Based on your facility’s needs and accessibility, a Medtronic Representative or authorized personnel may assist with updating programmers in your account. Refer to the original communication (below) for additional details.
ORIGINAL COMMUNICATION - MARCH 2020
This notice 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 Cardiac Resynchronization Defibrillator (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.
Medtronic 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 above-named 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 (7) 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.
Medtronic recommends continued routine management of your patients. We recognize that a one-time loss of stored device information may limit your ability to assess your patient’s clinical status – particularly when an audible alert, symptoms or VF shock delivery has been reported. Please work with your Medtronic Representative to identify data management options that may be available to your clinic.