BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 3961558 · Received June 16, 2014

    Report

    Report Number
    3004230826-2014-00060
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    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 FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VIBRANT SOUNDBRIDGE WAS EXPLANTED DUE TO A LOSS IN NATURAL HEARING IN (B)(6) 2014. THE RECORDED TONAL AUDIOGRAM SHOWED VERY HIGH BEARING THRESHOLDS, WHICH LEFT THE PATIENT OUT OF THE CRITERIA FOR THE VIBRANT SOUNDBRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351958 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention