High battery impedance may initiate Safety Mode in INGENIO™, VITALIO™, and ADVANTIO™ pacemakers and INLIVEN™, INTUA™, and INVIVE™ CRT-pacemakers

A Dear Healthcare Professional Letter has been issued by Boston Scientific Asia Pacific Pte Ltd to inform healthcare professionals that dual chamber INGENIO^™ family pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode prior to reaching the Explant battery indicator, when the device's battery exhibits high internal impedance. Although therapy is provided when a device is in Safety Mode, replacement is required as cases of myopotential oversensing-associated pacing inhibition, as well as phrenic nerve stimulation, prior to device replacement have been reported due to the non-programmable Safety Mode pacing parameters of the device. No affected device remain available for implant. Healthcare professionals are advised to schedule replacement if a device enters Safety Mode. In situations where non-programmable Safety Mode pacing parameters may not provide optimal support to a patient's cardiac condition, healthcare professionals are advised to consider early device replacement for dual chamber pacemakers with ≤4 years longevity remaining and CRT-Ps with ≤3 years longevity remaining. For patients who may not require early device replacement, healthcare professionals are advised to continue existing follow-up protocols until the longevity remaining reaches 1 year, and to follow-up every 3 months thereafter until replacement is indicated. Please refer to the letter for details. Published: 9 Jun 2021

Dear Healthcare Professional Letters