BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1140165 · Received September 2, 2008

    Report

    Report Number
    3004230826-2008-00019
    Event Type
    Injury
    Date Received
    September 2, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 14, 2008
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT SUFFERS FROM A BILATERAL MIXED HEARING LOSS. RECENTLY, THE HEARING THRESHOLD OF THE PT DECREASED AND THE PT NO LONGER HAD ANY BENEFITS USING HIS VIBRANT SOUNDBRIDGE. THE DEVICE WAS WORKING. THE SURGEON DECIDED TO EXPLANT THE VIBRANT SOUNDBRIDGE AND TO RE-IMPLANT THE PT WITH A COCHLEAR IMPLANT. THE PT WAS RE-IMPLANTED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH VORP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention