Azure S DR Atrial Lead Position Check (ALPC) Incorrectly Enabled – Software Update Available June 2020
Subset of Azure™ S DR pacemakers
Original Date of Communication:
STATUS UPDATE – NOVEMBER 2021
As of 8 Nov 2021, there have been eight (8) complaints reported due to the ALPC feature being enabled and over 45,000 devices distributed. No serious adverse events or patient harm have been reported.
This advisory has been addressed through release of new software to correct for the issue. Software application SW030 version 8.1 (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 - JUNE 2020
This communication provides notice on a software update available for a subset of Azure™ S DR pacemakers manufactured prior to February 2020 to addresses an issue in which the Atrial Lead Position Check (ALPC) was incorrectly enabled in a subset of this device model. ALPC is intended to operate as an optional feature in device models that offer atrial anti-tachy pacing therapies (ATP). Model Azure S DR does not offer atrial ATP. This update will ensure that ALPC is inactivated in all Azure S DR devices. Device therapies and battery performance are not affected by this issue.
As of 11 May 2020, there have been seven (7) complaints reported due to the ALPC feature being enabled and over 45,000 devices distributed. ALPC has the potential to pace at the programmed pacing rate for approximately 5 minutes at high output during its nightly assessment. No serious adverse events or patient harm have been reported.
Currently, updates are available for CareLink SmartSync™ Device Manager for this issue. The SmartSync Device Manager may receive software version 3.2.01 update by connecting the tablet to the internet. As of 4 June 2020, software application SW030 version 8.1 will be available via Medtronic Software Distribution Network (SDN) for Model 2090 and Encore programmers. In mid-June 2020, software application SW030 version 8.1will be available via secure USB for Model 2090 and Encore programmers.
Completion of programmer updates may be delayed due to COVID 19 pandemic-related facility restrictions. Based on your facility’s needs and accessibility, a Medtronic Representative or authorized personnel will assist with installing software on programmers in your account. Once a programmer is updated, the ALPC feature will be automatically inactivated at the patient’s next regularly scheduled interrogation if the device is in scope of this issue. There is no need to schedule patients to come in outside of their planned, scheduled visits due to this issue.