BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2180660 · Received May 5, 2011

    Report

    Report Number
    3004230826-2011-00028
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 2, 2011
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 WAS IMPLANTED IN (B)(6) 2003. THE FMT WAS PLACED ON THE INCUS. IN (B)(6), SHE ORDERED A NEWER MODEL OF AUDIO PROCESSOR. THE FUNCTIONAL GAIN WAS NOT SATISFACTORY. ANOTHER AUDIO PROCESSOR WAS TRIED, BUT THE PT STILL COMPLAINED ABOUT NO PERCEPTION OR AMPLIFICATION. AN RTF TEST WAS CARRIED OUT, WHICH WAS NEGATIVE.

    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