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Author Spotlight: Advancements in Impedance Monitoring for Cochlear Implant Surgery
Published on: August 4, 2023
A comprehensive analysis of MRI-related Cochlear implant adverse events reported by FDA's manufacturer and user
Amy Lin1, Arjun K Menta2, Syed Ameen Ahmad2
1The Ohio State University College of Medicine Columbus Ohio USA.
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.
Insights
MRI-conditional cochlear implants (CI) significantly reduced MRI-related adverse events. Devices with diametric magnets show no reported complications, indicating improved safety for patients undergoing MRI scans.
Area of Science:
- Biomedical Engineering
- Medical Device Safety
- Radiology
Background:
- Magnetic Resonance Imaging (MRI) poses risks for cochlear implant (CI) recipients due to device magnets.
- Adverse events, including dislodgement and pain, have been reported with traditional CIs during MRI scans.
- The development of MRI-conditional CIs aims to mitigate these risks.
Purpose of the Study:
- To identify and analyze MRI-related adverse events associated with cochlear implants (CI) using FDA MAUDE database.
- To determine if cochlear implants with diametric magnets are linked to a reduction in MRI-related adverse events.
Main Methods:
- Retrospective analysis of MRI-related adverse event reports from the FDA MAUDE database (01/01/2013–01/29/2023).
- Manual extraction of outcomes, interventions, device problems, electrode designs, and patient problems.
- Statistical analysis using R to group and analyze complications from three major CI manufacturers.
Main Results:
- A total of 668 MRI-related CI complications were reported (2.1% of 32,446 reports).
- Common issues included device dislodgment/migration (73.3%) and patient pain (31.6%).
- A significant decrease in median adverse events per year was observed after the introduction of MRI-conditional CIs (p=0.014).
Conclusions:
- The introduction of MRI-conditional cochlear implants has demonstrably reduced MRI-associated adverse events.
- No MRI-related complications have been reported for MRI-conditional CI devices from the three major US manufacturers.
- Devices featuring diametric magnets in MRI-conditional CIs appear to enhance patient safety during MRI procedures.
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