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

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.