BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 23802107 · Received December 15, 2025

    Report

    Report Number
    9710014-2025-01161
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    March 29, 2024
    Report Date
    January 12, 2026
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: BASED ON THE LIMITED INFORMATION FROM THE FIELD, A TECHNICAL DEVICE FAILURE IS ALLEGED. HOWEVER, NO FURTHER DETAILS ARE KNOWN AND THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. IN ADDITION, REPORTEDLY THE USER SUFFERED FROM FUNGAL INFECTION AND CHRONIC OTITIS MEDIA IN THE RIGHT EAR. REVIEW OF THE DEVICE'S STERILIZATION RECORDS SHOW THAT THE DEVICE HAS BEEN SUBJECT TO A VALID STERILIZATION PROCESS, THUS NO AVAILABLE INFORMATION POINTS TO THE IMPLANT BEING THE SOURCE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE USER SUFFERED FROM FUNGAL INFECTION AND CHRONIC OTITIS MEDIA IN THE RIGHT EAR. THE USER HAS BEEN RE-IMPLANTED WITH A NEW DEVICE.

    Description of Event or Problem · 0

    THE USER SUFFERED FROM FUNGAL INFECTION AND CHRONIC OTITIS MEDIA IN THE RIGHT EAR. IT WAS INITIALLY REPORTED THAT THE DEVICE WAS REMOVED TO CLEAR THE INFECTION, HOWEVER, AS PER ADDITIONAL INFORMATION RECEIVED, EXPLANTATION WAS RECOMMENDED BECAUSE OF AN OBSERVED DAMAGE OF THE DEVICE. IT IS NOT CLEAR WHEN OR HOW THE CONDUCTOR LINK BROKE. THE USER HAS BEEN RE-IMPLANTED AND IS HEARING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789408 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MPV MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH VORP

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention