BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 4020732 · Received July 30, 2014

    Report

    Report Number
    3004230826-2014-00071
    Event Type
    Injury
    Date Received
    July 30, 2014
    Date of Event
    January 10, 2014
    Report Date
    July 24, 2014
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPLANTED OF THE CONCERNED VIBRANT SOUNDBRIDGE ON (B)(6) 2014, AND THAT THE PT REPORTED TO SUFFER FROM DEVICE UNRELATED MENTAL HEALTH PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444421 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention