A Review of Reported Adverse Events in MRI-Safe and MRI-Conditional Cochlear Implants

Authors

Daniel E. Bestourous, Division of Otolaryngology-Head & Neck Surgery, George Washington University School of Medicine & Health Sciences.
Lauren Davidson, Division of Otolaryngology-Head & Neck Surgery, George Washington University School of Medicine & Health Sciences.
Brian K. Reilly, Department of Otolaryngology, Children's National Medical Center, Washington, DC.

Document Type

Journal Article

Publication Date

1-1-2022

Journal

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology

Volume

43

Issue

1

DOI

10.1097/MAO.0000000000003339

Abstract

OBJECTIVES: This study looks to examine how the development of diametric magnet cochlear implant devices (CIDs) has affected observed magnetic resonance imaging (MRI)-related adverse events and MRI safety measures. METHODS: A search of the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was conducted using the product code "MCM" for "Cochlear implants." Reports were included for analysis if they involved MRI in recipients of cochlear implantation. Included reports were stratified into two cohorts by year: 2010 to 2014 and 2015 to 2020, reflecting the FDA approval of diametric magnet cochlear implants in 2015. Extracted event variables included implant manufacturer, adherence to MRI protocol, patient injuries, and device malfunctions. RESULTS: The product code search query yielded a total of 27,305 reports, from which 584 reports were included for analysis. From 2010 to 2014, there were 109 adverse events and 30 pre-MRI explantations. Implant displacement was the most common device malfunction (n = 69, 87.3%), and pain was the most common patient injury (n = 16, 53.3%). From 2015 to 2020, there were 566 adverse events and 62 pre-MRI explantations. The most common device malfunction was implant displacement (n = 365, 94.6%) and pain was the most common patient injury (n = 114, 63.3%). Only 64/114 (56.1%) reports after 2015 reported adherence to the recommended MRI protocol. No adverse events occurred in patients with synchrony diametric-magnet CIDs. CONCLUSION: Despite the advent of FDA-approved MRI-safe diametric magnet devices, implanted patients are still experiencing injury, explantation, and device malfunction, and providers are reporting poor compliance with MRI safety protocols.

APA Citation

Bestourous, Daniel E.; Davidson, Lauren; and Reilly, Brian K., "A Review of Reported Adverse Events in MRI-Safe and MRI-Conditional Cochlear Implants" (2022). GW Authored Works. Paper 475.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/475

Department

Surgery