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CFx Longevity Estimator Software Error - Software Updates Available June 2020

CFx Longevity Estimator Software Error - Software Updates Available June 2020

Subset of IPG, ICD, CRT-P, CRT-D, and Micra TPS devices - June 2020
Original Date of Communication: June 2020

View specific models that this applies to

STATUS UPDATE – MAY 2021

This advisory has been addressed through release of several new software updates. The complete list of software applications available are listed in the table below. Medtronic representatives will work with local clinic and hospital staff to update programmers. Once a programmer has been updated, the correct longevity estimate for the affected devices will be displayed.

Note that as of September 2020 the Medtronic CareLink Network was updated for this advisory. All longevity estimates displayed on CareLink reflect accurate estimates (based on programmed settings and use conditions recorded by the device).

Phase 1 – June 2020 Phase 2 – January 2021
Azure™/Astra™ (SW030) v 8.1
Serena™/ Solara™/ Percepta™ (SW040) v 8.3
Visia AF™/ Visia AF™ MRI (SW035) v 8.2
Claria™/ Amplia™/ Compia™ (SW034) v 8.4 (US Only)
Viva™/Brava™/ Evera (SW016) v8.4
Evera™ MRI/ Primo™ MRI/ Mirro™ MRI(SW033) v8.5
Micra™ VR TPS (SW033) v8.2
Claria™/ Amplia™/ Compia™ (SW034) v 8.5
 

Table 1:Device family updates by phases

Note: The availability of software releases is specific to countries that follow FDA and CE Mark approvals. Release timing may differ for other geographies. Check with your local Medtronic representative.

As of May 6, 2021, there have been 596 total complaints received related to the software displaying a lower-than-expected longevity estimate. Within the 596 complaints reported, no patient harm was reported and twelve (12) devices were prematurely explanted after observing an inaccurate longevity estimate.

ORIGINAL COMMUNICATION - JUNE 2020

In October 2019, Medtronic identified the potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models.  This issue does not impact device functionality. Furthermore, the Recommended Replacement Time (RRT) remains an accurate indicator for device replacement. 

Through September 18, 2019 there have been three (3) reported complaints and there have been no (0) serious adverse events or deaths.

The inaccurate longevity estimation is limited to a well-defined subset of devices manufactured between October 2018 and April 2019, and only occurs in the middle (plateau) phase of the device life, as illustrated in the graph below. Approximately 53,100 devices worldwide, out of 1.23 million distributed or sold from the identified device families, are susceptible to displaying inaccurate longevity. 

The cause of the inaccurate longevity estimate is a slightly lower-than-typical discharge voltage during the plateau phase of the battery depletion curve (dashed line), compared to a typical voltage plateau (solid line), as illustrated in the graph below.  During this plateau period, the Carbon Monofluoride (CFx) in the battery cathode is powering the device.  Note, longevity estimates early after implantation and later in the device life are unaffected, as shown below.  The battery remains within operating specifications.

 
 
 

The Independent Physician Quality Panel recommends routine follow up in accordance with standard practice for these devices, as RRT function is normal and the battery longevity is unaffected.  There is no need to schedule patients to come in outside of their planned, scheduled visits due to this issue.The corrective fix is implemented in programmers, CareLink, and other systems which display device longevity. The patient’s device does not require an update. Follow the steps below as applicable to your clinic or hospital.  A local Medtronic Representative can assist in updating Model 2090/Encore programmers and SmartSync Device Managers in your facilities.

  • Model 2090 and Encore™ Programmers

These programmers will require new software to be installed to correct the displayed longevity estimator error. The software applications and version are listed in Table 1 above and can be installed via Medtronic Software Distribution Network (SDN) or via secure USB.

  • SmartSync™ Device Managers

These tablet-based programmers will require a software update to be installed via the internet - refer to Appendix A (below) for detailed instructions on how to download and install the updated application software. 

Completion of programmer updates may be delayed due to COVID 19 pandemic-related facility restrictions.  Based on your facility’s needs and accessibility, Medtronic Representative or authorized personnel will work with your facility as requested to complete the updates. Customers with Paceart systems should contact their support team to ensure the latest device update is applied. 

Note: Once a programmer is updated, the correct longevity estimate will display at the patient’s next regularly scheduled clinic visit.  Until all SmartSync Device Managers and Model 2090 and Encore programmers are updated, a difference in longevity estimates between programmers and CareLink Network-displayed longevitymay be observed

 


APPENDIX A – UPDATING SMARTSYNC™ DEVICE MANAGER

Until all SmartSync Device Managers and Model 2090 and Encore programmers are updated, you may observe a difference in longevity estimates between these programmers and CareLink-displayed longevity.

Updating Medtronic SmartSync™ Device Managers:

1) Connect tablet to internet and open the SmartSync App

  • The SmartSync App automatically checks for available updates each time it is opened.

2) If your tablet does not contain the most recent software, you will automatically receive a notification that a new version of the SmartSync App is available (3.2.01):

  • If pop-up messages appear with the option to “cancel” or to “update”, select “update”.

    • Medtronic Managed Tablets:If the App closes, find the Medtronic App Catalog, and selectInstall” to initiate the download.

    • Customer Owned Tablets:If the App closes, navigate to the AirWatch App Catalog or App Store and selectInstall” to initiate the download.

  • If you do not receive a notification that a new version of the SmartSync App is available, skip to Step 3.

3) Once you confirm the newest version of the SmartSync App is on your tablet, re-open the SmartSync App.

  • The app will automatically provide pop-up notifications informing you if there are new versions of device software applications that must be installed (see table below).

    • Select CONTINUE for each pop-up window that appears. If you do not receive any pop-up notifications when you open the SmartSync App, then your tablet contains the most recent versions of all available software.

Device Family SmartSync Application SW Version
Azure™/Astra™ DR and SR D00U003, Version 3.2.02
Percepta™/Serena™/Solara™ D00U004, Version 3.2.02

 

 



Specific Models This Applies To

DDBB1D1 Evera XT
DDBB1D4 Evera XT
DDBB2D1 Evera XT
DDBB2D4 Evera XT
DDBC3D1 Evera S
DDBC3D4 Evera S
DDMB1D1 Evera MRI XT
DDMB1D4 Evera MRI XT
DDMB2D1 Evera MRI XT
DDMB2D4 Evera MRI XT
DDMC3D1 Evera MRI S
DDMC3D4 Evera MRI
DDMD3D1 Primo
DDMD3D4 Primo
DDME3D1 Mirro
DDME3D4 Mirro
DTBA1D1 Viva XT
DTBA1D4 Viva XT
DTBA1Q1 Viva Quad XT
DTBA1QQ Viva Quad XT
DTBA2D1 Viva XT
DTBA2D4 Viva XT
DTBA2Q1 Viva Quad XT
DTBA2QQ Viva Quad XT
DTBB1D4 Viva S
DTBB1Q1 Viva Quad S
DTBB1QQ Viva Quad S
DTBB2D1 Viva S
DTBB2D4 Viva S
DTBB2QQ Viva Quad S
DTBC2D1 Brava
DTBC2D4 Brava
DTBC2Q1 Brava Quad
DTBC2QQ Brava Quad
DTMA1D1 Claria MRI
DTMA1D4 Claria MRI
DTMA1Q1 Claria MRI
DTMA1QQ Claria MRI
DTMA2D1 Claria MRI
DTMA2D4 Claria MRI
DTMA2Q1 Claria MRI
DTMA2QQ Claria MRI
DTMB1D1 Amplia MRI
DTMB1D4 Amplia MRI
DTMB1Q1 Amplia MRI
DTMB1QQ Amplia MRI
DTMB2D1 Amplia MRI
DTMB2D4 Amplia MRI
DTMB2Q1 Amplia MRI
DTMB2QQ Amplia MRI
DTMC1D1 Compia MRI
DTMC1QQ Compia MRI
DTMC2D1 Compia MRI
DTMC2D4 Compia MRI
DTMC2QQ Compia MRI
DVAB1D1 Visia AF
DVAB1D4 Visia AF
DVBB2D1 Evera XT
DVBC3D1 Evera S
DVBC3D4 Evera S
DVFB1D1 Visia MRI AF
DVFB1D4 Visia MRI AF
DVFB2D1 Visia MRI AF XT
DVFB2D4 Visia MRI AF XT
DVFC3D1 Visia MRI AF S
DVFC3D4 Visia MRI AF S
DVMB1D4 Evera MRI XT
DVMB2D1 Evera MRI XT
DVMB2D4 Evera MRI XT
DVMC3D1 Evera MRI S
DVMC3D4 Evera MRI S
DVMD3D1 Primo
DVMD3D4 Primo
DVME3D1 Mirro
DVME3D4 Mirro
W1DR01 Azure XT DR
W1SR01 Azure XT SR
W1TR01 Percepta CRTP MRI
W1TR02 Serena CRTP MRI
W1TR03 Solara CRTP MRI
W1TR04 Percepta CRTP MRI
W1TR05 Serena CRTP MRI
W1TR06 Solara CRTP MRI
W2DR01 Azure XT DR
W2SR01 Azure XT SR
W3DR01 Azure S DR
W3SR01 Azure S SR
W4TR01 Percepta Quad CRTP MRI SureScan
W4TR02 Serena Quad CRTP MRI SureScan
W4TR03 Solara Quad CRTP MRI SureScan
W4TR04 Percepta Quad CRT-P MRI SureScan
W4TR05 Serena Quad CRTP MRI SureScan
W4TR06 Solara Quad CRTP MRI SureScan
X2DR01 Astra XT DR MRI SureScan
X2SR01 Astra XT SR MRI SureScan
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