Auditory brainstem implants: an analysis of adverse events in the MAUDE database.

Autor: Speed OE; University of Arkansas for Medical Sciences - Little Rock, AR, USA., Farsi S; University of Arkansas for Medical Sciences - Little Rock, AR, USA., Rickels K; University of Arkansas for Medical Sciences - Little Rock, AR, USA., Patel VA; Department of Otolaryngology - Head and Neck Surgery, University of California San Diego, La Jolla, CA, USA; Division of Pediatric Otolaryngology, Rady Children's Hospital - San Diego, San Diego, CA, USA., Bareiss A; University of Arkansas for Medical Sciences - Little Rock, AR, USA., Dornhoffer J; University of Arkansas for Medical Sciences - Little Rock, AR, USA; Arkansas Children's Hospital - Little Rock, AR, USA., Saadi RA; University of Arkansas for Medical Sciences - Little Rock, AR, USA; Arkansas Children's Hospital - Little Rock, AR, USA. Electronic address: rsaadi@uams.edu.
Jazyk: angličtina
Zdroj: Neuro-Chirurgie [Neurochirurgie] 2024 Sep; Vol. 70 (5), pp. 101570. Date of Electronic Publication: 2024 May 28.
DOI: 10.1016/j.neuchi.2024.101570
Abstrakt: Objective: Auditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events.
Study Design: This is a study of a multi-institutional database maintained by the US FDA.
Setting: A database analysis was performed via collaboration of multiple clinicians at tertiary referral centers.
Methods: The MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term "Implant, Auditory Brainstem" and reviewing all reports with the basic search term "Brainstem Implant". All collected reports were individually reviewed.
Results: A total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation.
Conclusions: Poor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.
(Copyright © 2024 Elsevier Masson SAS. All rights reserved.)
Databáze: MEDLINE
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