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

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 ¼ 69, 87.3%), and pain was the most common patient injury (n ¼ 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 ¼ 365, 94.6%) and pain was the most common patient injury (n ¼ 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.

The Use and Utility of Food and Drug Administration Adverse Event Data from the Manufacturer and User Facility Device Experience Database in Otology: A Systematic Review

“…Such objectives are notably appropriate uses of MAUDE as they are minimally affected by the database's limitations. Similarly, the conclusion reported by Bestourous et al (8) that there needs to be increased awareness of the correct magnetic resonance imaging protocol in patients with cochlear implants is an additional clinically applicable conclusion found in the reviewed studies. These instances are unique because rather than attempting to interpret the data in aggregate, they lean into MAUDE's design by qualitatively identifying a use pattern leading to AEs and raising awareness of it.…”

“…As mentioned previously, one of the most important limitations is that, because MAUDE studies are case series and there is no listed total number of cases, it is impossible to calculate a true incidence rate. Although all studies in this review acknowledged this limitation, several studies still attempted to statistically assess relative rates between devices and across time points (8–11). Although assessing relative rates may be plausible if MAUDE truly contained a reasonably complete list of mandatory AEs, MAUDE's data are unfortunately too heterogenous, leading to unacceptable selection bias.…”

“…Three evaluated cochlear implants, two evaluated ossicular prostheses (ossicular chain reconstruction), two evaluated osseointegrated hearing implants (osseointegrated auditory implants), and one evaluated illuminated operating microscopes commonly used during otologic surgery. Four of the studies used comparative and descriptive statistical analyses (8)(9)(10)(11), and the remaining four studies solely used descriptive analyses (6,(12)(13)(14). The characteristics of each study, including objective, variables extracted, devices, manufacturers, and additional data sources, are further presented in Table 1, whereas the outcomes analyzed in each study are summarized in Table 2.…”

“…All except one study had a clearly described question or objective. All studies had a clearly described exposure and clear, well-described results (6,(8)(9)(10)(11)(12)(13). However, none of the studies had a clearly described population, consecutive participants, adequate length of follow-up, or data on the comparability of their participants.…”

“…However, none of the studies had a clearly described population, consecutive participants, adequate length of follow-up, or data on the comparability of their participants. Four of the studies had clearly and consistently defined outcome measures (8,9,11,13). Finally, only four studies used appropriate statistical analyses (6,(12)(13)(14).…”