Field Safety Notice Update
Boston Scientific is providing an update to the June 2021 advisory regarding the potential for high battery impedance in INGENIO family of DR EL pacemakers and CRT-Ps, which may cause the device to enter Safety Mode.
The affected devices are the INGENIO family of DR EL pacemakers and CRT-Ps, including VITALIO, ADVANTIOT, INLIVENT, INTUA, and INVIVET models.
Background
The high battery impedance may cause the device to exhibit transient voltage decreases during high-power consumption, leading to system resets and potentially entering Safety Mode.
The occurrence rate for this behavior is up to 8% at 9 years, 12% at 10 years, and 49% at 11 years.
Clinical Impact
Safety Mode provides back-up pacing, but may not provide optimal support for patients’ cardiac conditions, potentially leading to pacing inhibition, muscle stimulation, or heart failure.
There have been three reported deaths in pacemaker-dependent patients associated with this behavior.
Recommendations
Physicians are advised to identify patients at risk of harm due to Safety Mode’s non-programmable parameters and replace devices when the battery longevity reaches 4 years or less for DR EL pacemakers and 3 years or less for CRT-Ps.
Regular system follow-up and medical records updates are also recommended.
Manual:
Download: INGENIO EL and CRT-P Battery High Impedance Update
Chat: Powered By VoiceSphere