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Adverse events associated with Vibrant Soundbridge: A MAUDE study
Journal article   Peer reviewed

Adverse events associated with Vibrant Soundbridge: A MAUDE study

Christopher Yam, Adam Hammer, Esther Lee, Timothy Shaver, Punam Thakkar and Ashkan Monfared
American journal of otolaryngology, v 45(4), 104273
01 Jul 2024
DOI: https://doi.org/10.1016/j.amjoto.2024.104273
PMID: 38574515
Featured in Collection :   UN Sustainable Development Goals @ Drexel

Abstract

Life Sciences & Biomedicine Otorhinolaryngology Science & Technology
Objective: To summarize adverse events and their root causes reported to the United States Food and Drug Administration (FDA) on Vibrant Soundbridge (VSB) hearing device (Med-El, Innsbruck, Austria), an active middle ear implant for patients with moderate to severe hearing loss. Materials and methods: The FDA 's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of VSB adverse events from January 1, 2012, to July 27, 2022. Results: Six hundred sixty-three total medical device reports were identified, from which 913 adverse events were extracted. Of these, 498 (54.5 %) were adverse events to patients (AEPs), while 415 (45.5 %) were device malfunctions (DMs). The most common AEPs were hearing performance issues 428 (85.9 %). The most common DMs were compromised conductive link 125 (30.1 %). Root causes identified for DMs were iatrogenic 85 (58.6 %), patient -related 28 (19.3 %), and trauma and external causes 32 (22.1 %). The most common iatrogenic root cause 12 (14.1 %) involved damage to the conductive link during revision surgery. The most common patientrelated causes of DMs were excessive middle ear tissue growth 16 (57 %), and abrupt body movements 5 (28.6 %). The most common external cause of DM was cleaning of the ear canal or mastoid cavity 20 (62.5 %). Conclusions: Despite its well-known limitations, the MAUDE database provides valuable information on possible complications of VSB as it relates to device malfunction or adverse events for patients. Implementation of standardized reports with relevant and well-defined categories could certainly allow for a more meaningful analysis.

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Collaboration types
Domestic collaboration
Web of Science research areas
Otorhinolaryngology
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