Safety of a pacemaker mode intended to protect patients.

ABSTRACT:

Background

In 2021, Boston Scientific (BSC) announced that its Ingenio pacemakers (PMs) could exhibit high internal battery impedances (HIBIs) and trigger the safety mode (SM) that should preserve pacing when PM function is jeopardized. SM is VVI or biventricular pacing, 72.5 bpm, and unipolar, with a sensitivity of 0.25 mV. In 2023, BSC said SM may pause pacing and 3 deaths occurred in PM-dependent patients. In 2024, BSC warned that some Accolade PMs had HIBI and SM could occur.

Objective

This study aimed to quantify adverse events (AEs) associated with SM and compare them with Abbott's backup (BU), Medtronic's reset (RE), and Biotronik's backup mode.

Methods

The Food and Drug Administration's Manufacturer and User Facility Device Experience database was searched fro

SUBMITTER: Hauser RG 

PROVIDER: S-EPMC12411951 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature