BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1211765 · Received October 24, 2008

    Report

    Report Number
    3004230826-2008-00027
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 13, 2008
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED, AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT. THE PATIENT WAS IMPLANTED IN ANOTHER COUNTRY BUT WAS EXPLANTED IN DIFFERENT COUNTRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO THE DEVICE'S EXTRUSION AND INFECTION.

    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 Required Intervention