Summary of Advisory Population
A subset of approximately 13% of devices from the ACCOLADE family, built before Sep 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to high battery impedance.
The advisory population was defined based on battery cathode processing practices performed by a subset of manufacturing operators whose cathode processing techniques demonstrate higher concentration of lithium salts.
Affected Devices
The affected devices include:
- ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 Standard Life (SL) and Extended Life (EL) pacemakers
- VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps)
Clinical Impact
Safety Mode may not provide optimal support of a patient’s cardiac condition, and pacing inhibition due to myopotential oversensing is a potential risk.
Recommendations
Identify patients within the advisory population who are at risk of harm due to non-programmable parameters in Safety Mode and schedule device replacement promptly.
Remote monitoring remains critical for device management capability and will be an important means to detect onset of high battery impedance when the future software update becomes available.
Manual:
Download: Urgent Field Safety Notice: ACCOLADE Family of Pacemakers and CRT-Ps
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