BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1812360 · Received August 16, 2010

    Report

    Report Number
    3004230826-2010-00037
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 16, 2010
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNTIL (B)(6), 2010, THE PT WAS ABLE TO HEAR VERY WELL WITH THE VIBRANT SOUNDBRIDGE. THE OTHER DAY, HE NO LONGER HAD ANY HEARING SENSATION. THE AUDIO PROCESSOR WAS CHECKED AND IT WORKED PROPERLY. THE IMPLANT WAS CHECKED ON (B)(6), 2010. AT SEVERAL RTF MEASUREMENTS, AN OUTPUT SIGNAL COULD NOT BE REPRODUCED. ACCORDING TO THE PT, THERE HAS NOT BEEN ANY FALL OR IMPACT TO THE HEAD.

    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 42 YR