PO-707-01 MINIATURIZED IMPLANTABLE CARDIAC MONITOR WITH A LONG SENSING VECTOR (BIOMONITOR III): INSIGHTS FROM MAUDE DATABASE

Abstract

Implantable Cardiac Monitors (ICMs) are used to detect bradycardia, asystole, atrial fibrillation, or other heart rhythm disturbances. BIOMONITOR III (Biotronik, Berlin, Germany) is new generation ICM combining a long sensing vector in a miniaturized profile. We queried the FDA Manufacturer And User Facility Device Experience (MAUDE) database to assess complications types with BIOMONITOR III. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse (MDR) events representing a collection of both common and uncommon events. A MAUDE database search was conducted on November 23, 2021, for reports received between August 1, 2019 to October 31, 2021 to capture all adverse events. After removing duplicate entries, a total of 580 events were reported in 321 MDRs. 34.5% (n=200) were insertion-site events, while 16.4% (n=95) were malfunction related events. The most frequent device malfunction events were: failure to interrogate [24.2%, n=23 post-cardioversion and 1% (n=1) post MRI], sensing issues (20%, n=19), transmission failure (14.7%, n=14) and poor/loss of signals (12.6%, n=12). Of insertion-site events, device externalization (33%, n=66) followed by spontaneous device fall off (23.5%, n=47) and device infection (22%, n=44) were most common. Overall, 43.6% (n=253) underwent device explantation. Several concerns have been reported inherent to the device function (especially device failure post cardioversion), making this a unique reported event. Robust, transparent monitoring mechanisms are warranted especially with newer technologies