A comprehensive analysis of MRI-related Cochlear implant adverse events reported by FDA's manufacturer and user facility device experience database

Abstract

Objective

Identify MRI-related cochlear implant (CI) adverse events from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database and determine whether devices with diametric magnets are associated with reduced adverse events.

Methods

Data on MRI-related adverse events were collected from the MAUDE database for reports filed between 01/01/2013 and 01/29/2023. Outcomes and interventions were manually extracted. Device problems, electrode designs, and correlated patient problems were grouped and analyzed using R.

Results

All CI complications were derived from three manufacturers: Cochlear Limited, Advanced Bionics, and MED-EL. MRI-related CI complications occurred in 668 of 32,446 reports (2.1%). MRI-related CI complications increased from 32 reports (4.8%) in 2013 to a peak of 142 reports (21.3%) in 2019 and decreased to 56 reports (8.4%) in 2022. The most common MRI-related device problems were dislodgment/dislocation (39.9%, n = 266) or migration/expulsion (33.4%, n = 223). The most frequently identified patient problems identified were pain (31.6%, n = 211), hearing impairment (4.9%, n = 33), unspecified medical problems (3.7%, n = 25), implant failure (3.0%, n = 20), and injury (1.5%, n = 10). Of these, 358 reports (53.6%) contained the date of device manufacture. The median MDR per year decreased from 11 in the 3 years before each manufacturer released their MRI-conditional CI to 0 in the 3 years following the release (p = 0.014).

Conclusions

The introduction of MRI-conditional CIs has successfully reduced MRI-associated adverse events. There have been no reported cases of MRI-related CI complications for devices containing the new MRI-conditional magnets for each of the three major US manufacturers.

Level of evidence

N/A