Potential for Autonomous Cursor Motion

CareLink™ 2090 Programmer
Original Date of Communication: July 2024

View specific models that this applies to

STATUS UPDATE - OCTOBER 2024

As of 16 October 2024, Medtronic has 379 reports of autonomous cursor behavior including reports identified during the software update. There are no additional reports of unintended therapy delivered. There have been no reports of permanent harm or death associated with this behavior.

ORIGINAL COMMUNICATION - JULY 2024

Medtronic CareLink™ 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.

Through 11 June 2024, Medtronic has received 23 reports of autonomous cursor behavior, with 2 reports of unintended therapy delivered when the programmer was not under the control of trained personnel during a patient session. There have been no reports of permanent harm or death associated with this behavior.

If a programmer is unattended while in an active patient device session, a risk to patients may exist if an autonomous cursor motion engages in unintended programming. Medtronic estimates that 1.0% of Model 2090 programmers with serial number prefixes PKK0 or PKK1 could display this behavior when updated to software version 3.2 or higher.

INSTRUMENT MANAGEMENT RECOMMENDATIONS:

Software updates are necessary to maintain proper programmer function. Medtronic representatives will assist in performing the software update on all Medtronic CareLink™ 2090 programmers and assess proper function. Medtronic representatives will assist with returning programmers needing repair or replacement.