BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2860422 · Received December 5, 2012

    Report

    Report Number
    3004230826-2012-00083
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 19, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO (B)(4) WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERFORMANCE WITH THE VIBRANT SOUNDBRIDGE WAS NO LONGER SUFFICIENT. THERE WAS NOT ENOUGH AMPLIFICATION DUE TO THE PT NO LONGER BEING IN THE INDICATION CRITERIA FOR A VIBRANT SOUNDBRIDGE. THE IMPLANT WAS REPORTED TO BE FUNCTIONAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention