Adverse events associated with Vibrant Soundbridge: A MAUDE study

Authors

Christopher Yam, Drexel University College of Medicine, Philadelphia, PA, United States of America. Electronic address: cwy25@drexel.edu.
Adam Hammer, George Washington University School of Medicine and Health Sciences, Division of Otolaryngology-Head and Neck Surgery, Washington, DC, United States of America.
Esther Lee, George Washington University School of Medicine and Health Sciences, Division of Otolaryngology-Head and Neck Surgery, Washington, DC, United States of America.
Timothy Shaver, George Washington University School of Medicine and Health Sciences, Division of Otolaryngology-Head and Neck Surgery, Washington, DC, United States of America.
Punam Thakkar, George Washington University School of Medicine and Health Sciences, Division of Otolaryngology-Head and Neck Surgery, Washington, DC, United States of America.
Ashkan Monfared, George Washington University School of Medicine and Health Sciences, Division of Otolaryngology-Head and Neck Surgery, Washington, DC, United States of America.

Document Type

Journal Article

Publication Date

1-1-2024

Journal

American journal of otolaryngology

Volume

45

Issue

4

DOI

10.1016/j.amjoto.2024.104273

Keywords

Adverse events; MAUDE; Manufacturer and user facility device experience; Vibrant Soundbridge

Abstract

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 patient-related 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.

APA Citation

Yam, Christopher; Hammer, Adam; Lee, Esther; Shaver, Timothy; Thakkar, Punam; and Monfared, Ashkan, "Adverse events associated with Vibrant Soundbridge: A MAUDE study" (2024). GW Authored Works. Paper 5395.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/5395

Department

Surgery