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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.
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.
Insights
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.
