Field Safety Notice: High Battery Impedance May Initiate Safety Mode
Boston Scientific has determined that dual chamber INGENIOTM family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life when the device’s battery exhibits high internal impedance.
This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing.
Affected Devices
Approximately 48,000 active dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population.
No affected devices remain available for implant.
Recommended Actions
If a device enters Safety Mode, schedule replacement. In situations where non-programmable Safety Mode pacing parameters may not provide optimal support of patient’s cardiac condition, consider early device replacement.
Manual:
Download: INGENIOTM Family DR EL Pacemakers and CRT-Ps User Manual
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