Boston Scientific Accolade Pacemaker Software Update and Revision

A subset of product manufacturers (approximately 13%) who built devices before Sep 2018 used battery cathode processing techniques that resulted in higher concentration of lithium salts, which can be associated with high battery impedance later in device life.  This results in an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations towards the end of device life.

The non-programmable Safety Mode pacing parameters may not provide adequate support of a patient’s heart rate. Safety Mode may result in inappropriate pacing inhibition/pauses, muscle stimulation (e.g., skeletal muscle or phrenic nerve stimulation), or heart failure decompensation prior to device replacement. The most serious reported adverse event has been loss of pacing, resulting in serious injury or life-threatening outcomes.

Due to this concern, Boston Scientific initially recommended prophylactic generator change for impacted devices with ≤4 years of battery life remaining, particularly in patients at risk of serious harm (pacer-dependence) due to the non-programmable parameters in Safety Mode Details of the initial advisory from Dec 2024 can be found via this link of our initial reporting on their safety alert.

In August 2025, Boston Scientific launched Model 3869 v2.04 software that was designed to prevent potential initiation of Safety Mode due to the high battery impedance condition in these devices. This software update introduced two separate mechanisms to mitigate risks associated with this battery condition. First, the software enabled detection of an elevated battery impedance condition via a telemetry activated battery test, triggering a red alert (voltage is too low for projected remaining capacity, also known as Code-1003). Second, the software disables ZIP™ telemetry (i.e., wandless, two-way radiofrequency communication) when the battery reaches a high impedance state to prevent initiation of Safety Mode in an ambulatory setting.

Unfortunately, after release of the software update some unintended behaviors were noted:

1. The new software update reduces but does not fully eliminate the risk of safety mode initiation. The update was originally designed to completely eliminate the potential for initiation of safety mode by disabling wandless telemetry in all pacemakers for whom a high battery impedance state is detected. While  the software update  disables active telemetry, it does not disable telemetry wake ups..
2. The new software has the potential to initiate a false positive response in the presence of a magnet, that results in disabling of wandless telemetry sessions. For patients monitored via LATITUDE, this will trigger an alert message indicating an erroneous explant indicator stating that LATITUDE is no longer available and prompting providers to contact Technical Services.

Despite these limitations, Boston Scientific continues to recommend upgrading device firmware using Model 3869 v2.04 software on the Model 3300 LATITUDE programmer. Following the upgrade, prophylactic generator replacement is no longer advised for high-risk patients in this subgroup; however, these patients should remain under close surveillance.