Major adverse clinical events associated with implantation of a leadless intracardiac pacemaker

Abstract

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On the Management of Ventricular Arrhythmias Following Leadless Pacemaker Implantation

“… 4 In a report of the MAUDE database, three episodes of VF/VF were reported, all in the setting of perforation and effusion. 5 …”

Leadless pacemaker perforations: Clinical consequences and related device and user problems

“…Subsequent studies suggested that Micra implant success rates were high and the incidence of major adverse clinical events (MACEs) was low 2–6 . Recently, we reported our analysis of MACE associated with Micra‐TPS implantation based on information obtained from the USA Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database 7 . While their incidence appeared to be low, we found a concerning number of deaths and other MACE caused by Micra‐TPS cardiac perforations.…”

Leadless pacemaker implantation complications and the denominator problem

“…The basis of the analyses is principally the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, but it also includes reports to other FDA databases. The analysis builds on a prior report of safety events related to the Micra® leadless pacing device this time with more than 50% more events 2 . Differences in search strategies are not provided, but the present study reports the use of proprietary software to improve completeness and a slightly larger period of interest (7 months).…”