UPDATE TO MEDICAL DEVICE CORRECTION
Software Update Now Available

For All Models of Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™


April 2017

Dear Physician or Healthcare Professional,

In December 2016, Medtronic issued an Urgent Medical Device Correction letter regarding a device software issue that involved a specific programming sequence that may result in loss of LV pacing in all models of Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ devices.

Medtronic has now obtained the necessary regulatory approvals and is ready to begin applying a programmer software update (SW034 Software Version 8.2) to correct the issue in the devices. In addition, as previously described in the December 2016 letter (attached), the software update also addresses a transient mode switch behavior that may occur in MRI Quadripolar CRT-D device models (Claria MRI™, Amplia MRI™ and Compia MRI™).

Once installed by a Medtronic Representative on the programmer, an in-clinic device interrogation will update the patient’s device automatically. To prevent possible recurrence of the issues, the patient must continue to be programmed only with programmers that have this update. The loss of LV pacing issue will still occur if the specific programming sequence described in the original advisory letter is performed using a programmer not updated with SW034 Software Version 8.2.

Directions on how to apply this update to patient devices and to verify that devices are operating correctly can be found in Appendix A. If you have any questions, or if we can be of further assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Sincerely,

Tim Samsel signature

Tim Samsel
Vice President, Quality and Regulatory Affairs
Medtronic Cardiac Rhythm Heart Failure (CRHF)


Appendix A

Q1. How do clinics apply this software update to each patient’s device?
For Claria MRI™ and Amplia MRI™ devices or Quadripolar models of Compia MRI™ CRT-D SureScan™ devices, once SW034 Software Version 8.2 has been installed on the programmer, each patient’s device will automatically be updated during device interrogation by an updated programmer.

As long as a programmer with SW034 Software Version 8.2 is used at each subsequent in-clinic session, the device will not be susceptible to the issues. If a non-updated programmer is used for programming, the loss of LV pacing issue described in the December 2016 advisory may be re-introduced by the programming sequence described in the letter.

If an electrical reset occurs in a device (which will clear the update), the device update will automatically be re-installed during interrogation of the device with an

Note: The device update can only be installed via interrogation by an updated Medtronic programmer containing SW034 Software Version 8.2.

Q2. How can I verify whether a patient’s device has been updated?
To verify that all Claria MRI™ and Amplia MRI™ devices or Quadripolar models of Compia MRI™ devices have successfully received the update:

ON A PROGRAMMER:
- Generate a Strip Chart, Full Size or PDF printout of the Parameters screen
- Verify the Software Version indicates “SW034 Software Version 8.2” (see arrows - Figure 1a and 1b) If the software model does not indicate SW034 Software Version 8.2, the patient’s device will need to be interrogated with a programmer that has been installed with the updated software.

Figure 1a: Strip Chart Printout showing updated Software Version in the upper right corner.

Figure 1a

Figure 1b: Full Page Printout showing updated Software Version in the lower left corner.

Figure 1b

Q3. If a patient’s device has previously shown evidence of loss of LV pacing due to the issue described in the December 2016 advisory, how can I verify a Claria MRI™ or Amplia MRI™ device is operating correctly post-software update?
Interrogation with a programmer that has been updated to SW034 Software Version 8.2 will restore LV pacing. To confirm that LV pacing has been restored, view the ECG and EGM morphology waveforms.

The histogram LV and BiV pacing percentages will begin to update as soon as LV pacing is restored, but it will take some time for enough events to accumulate to materially impact the values in the Histogram Report. The Report will show appropriate LV and BiV pacing percentages at the next remote or in-office follow-up.

Note: To prevent possible recurrence of the issues, the patient must continue to be programmed only with programmers that have this update. The loss of LV pacing issue will still occur if the specific programming sequence described in the original advisory letter is performed using a programmer not updated with SW034 Software Version 8.2.