Complications involving the subcutaneous implantable cardioverter-defibrillator: Lessons learned from MAUDE.

ABSTRACT:

Background

Reports on the subcutaneous implantable cardioverter-defibrillator (S-ICD) cumulatively demonstrate a low rate of complications, but clinical experience with this technology is limited compared with transvenous devices.

Objective

The purpose of this study was to describe and analyze S-ICD complications reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience database.

Methods

We reviewed all S-ICD events reported to the Manufacturer and User Facility Device Experience submitted over 24 months (from February 2016 through February 2018) through a prospective and standardized approach at a time when an estimated 15,000 S-ICDs were in service.

Results

After removing duplicate entries and nonclinical events (n = 493)

SUBMITTER: Zeitler EP 

PROVIDER: S-EPMC7519585 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature