BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2190854 · Received July 27, 2011

    Report

    Report Number
    3004230826-2011-00041
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    July 21, 2011
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CT SCAN SHOWS THE FMT HAVING MOVED INTO THE MIDDLE EAR CAVITY. THE PT'S HEARING AND SPEECH DISCRIMINATION HAS DETERIORATED. A REVISION SURGERY TO REVISE THE POSITION OF THE FMT WAS CARRIED OUT ON (B)(6), 2011. DURING WHICH THE FMT LEAD WAS CUT AND THE DEVICE WAS THEN EXPLANTED.

    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 UNK Required Intervention