BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2181350 · Received July 8, 2011

    Report

    Report Number
    3004230826-2011-00044
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR 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 PATIENT IS NO LONGER ABLE TO HEAR WITH HIS DEVICE. THE DEVICE IS WORKING ACCORDING TO RTF (REVERSE TRANSFER FUNCTION) MEASUREMENTS. A REVISION SURGERY IS PLANNED TO REPOSITION THE FMT (FLOATING MASS TRANSDUCER), WHICH WAS INITIALLY LOCATED AT THE ROUND WINDOW.

    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 70 YR