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Adverse events associated with Vibrant Soundbridge: A MAUDE study.
Christopher Yam1, Adam Hammer2, Esther Lee2
1Drexel University College of Medicine, Philadelphia, PA, United States of America.
American Journal of Otolaryngology
|April 4, 2024
Summary
Adverse events and device malfunctions with the Vibrant Soundbridge (VSB) hearing device were analyzed. Iatrogenic causes, particularly damage during surgery, were the most common root cause for VSB device malfunctions.
Area of Science:
- Otolaryngology
- Biomedical Engineering
- Medical Device Safety
Background:
- The Vibrant Soundbridge (VSB) is an active middle ear implant for moderate to severe hearing loss.
- Understanding adverse events and device malfunctions is crucial for patient safety and device improvement.
Purpose of the Study:
- To summarize adverse events and their root causes for the VSB hearing device.
- To analyze data reported to the US Food and Drug Administration (FDA).
Main Methods:
- Utilized the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.
- Queried reports of VSB adverse events from January 1, 2012, to July 27, 2022.
Main Results:
- Identified 663 medical device reports with 913 adverse events: 498 patient adverse events (AEPs) and 415 device malfunctions (DMs).
- Most common AEPs were hearing performance issues (85.9%). Most common DMs involved a compromised conductive link (30.1%).
- Iatrogenic causes (58.6%) were the leading root cause for DMs, often involving damage to the conductive link during revision surgery.
Conclusions:
- The MAUDE database offers valuable insights into VSB complications despite limitations.
- Standardized reporting could enhance the meaningfulness of future analyses of device-related adverse events.
