BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 3994503 · Received July 23, 2014

    Report

    Report Number
    3004230826-2014-00068
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 16, 2014
    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 MANUFACTURER 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 HAD EXPERIENCED A LARGE HEMATOMA IN THE MIDDLE EAR SPACE FOLLOWING IMPLANTATION AND THAT THE FMT HAD BEEN DISPLACED OFF THE INCUS. AT ACTIVATION THE PT HAD NO ACCESS TO SOUND WITH THE DEVICE REPORTEDLY, A REPOSITION SURGERY WAS CONDUCTED WHERE THE FMT WAS RE-CRIMPED FIRMLY TO THE INCUS. HOWEVER DURING RE-ACTIVATION THE PT HAD TO ACCESS TO SOUND WITH THE DEVICE. THE BONE AND AIR CONDUCTION THRESHOLDS HAVE REMAINED UNCHANGED. RE-IMPLANTATION WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432347 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1