BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1990655 · Received February 8, 2011

    Report

    Report Number
    3004230826-2011-00005
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    May 1, 2010
    Report Date
    January 24, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    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 F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OTOSCOPY AND A VIDEO ENDOSCOPY REVEALED THE CONDUCTOR LINK OF THE VIBRANT SOUNDBRIDGE BEING EXPOSED IN THE EXTERNAL EAR CANAL. THE PT WAS NOT DERIVING THE OPTIMUM BENEFIT OUT OF THE AUDIO PROCESSOR. THE PT WAS RE-IMPLANTED ON (B)(6), 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention