Customer Communications
CFx Longevity Estimator Software Error

CFx Longevity Estimator Software Error

Subset of IPG, ICD, CRT-P, CRT-D, and Micra TPS devices
Original Date of Communication: October 2019

View specific models that this applies to

Affected Programmers & Remote Monitoring Software Apps

Affected Devices
2090 CareLink Programmer
29901 Encore Programmer
CareLink Network Application Software 2491
CareLink SmartSync™ Device Manager
MyCareLink Heart™ Mobile Application
Subset of the following devices:
Claria MRI™/Amplia MRI™/Compia MRI™/Viva™/Brava™ CRT-Ds
Visia AF™/ Visia AF MRI™/Evera™/ Evera MRI™/Primo MRI™/Mirro MRI™ ICDs
Azure™/Astra™ IPGs
Percepta™/Serena™/Solara™ CRT-Ps
Micra™TPS
 

Advisory

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.

 
 
 
 

Software updates to programmers and remote monitoring systems are under development to correct for the inaccuracy in longevity estimates. Medtronic is targeting regulatory approval and release of the software updates to begin in mid-2020. Once available, Medtronic will inform you of the availability of the software and work with you to install the software onto clinic and hospital programmers. Software updates to individual patient devices will not be necessary to correct this issue, since longevity estimation resides on the programmers, mobile app and the CareLink Network

Internal analysis estimates approximately 11% of the 53,100 identified devices are projected to display an inaccurate longevity estimate before mid-2020.

Patient Management Recommendations

We realize that each patient requires unique clinical considerations.  In consultation with our Independent Physician Quality Panel, Medtronic provides the following guidance:

  • Prophylactic device replacement is not recommended, as device functionality, true longevity and the RRT indicator are not impacted by the inaccurate longevity estimate.

        Until the software update becomes available:

  • Continue normal patient follow-up in accordance with standard practice. 

  • Per labeling, continue to use the RRT notification to identify when device replacement should be scheduled. Where available, utilize the low battery voltage RRT audible alert or wireless CareAlert™.

  • At any time, if a lower-than-expected remaining longevity estimate occurs, contact Medtronic Technical Services for assistance – additional analysis of stored device information will be required to assess if the decreased longevity estimate is due to this issue.

Note: For Azure IPG or Percepta/Serena/Solara CRT-P patients remotely monitored via the MyCareLink Heart mobile app, patients’ mobile app longevity estimates will not change until the software update has been released. 

We sincerely regret any difficulties this may cause you and your patients. Medtronic remains dedicated to patient safety and will continue to monitor device performance to ensure we meet your needs and those of your patients.


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
DDMD3D4 Primo
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
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
www.medtronic.com/productperformance 726050