BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1679486 · Received May 6, 2010

    Report

    Report Number
    3004230826-2010-00023
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    January 1, 2010
    Report Date
    May 30, 2010
    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 MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT. THIS DEVICE AHS BEEN MANUFACTURED BY SYMPHONIX CORP. VIBRANT MED-EL TOOK OVER THE ASSETS FROM SYMPHONIX CORP IN 2003.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT COMPLAINED OF SOME INTERMITTENCIES SOME MONTHS AGO WHEN MOVING THE IMPLANT BODY. ANOTHER AUDIO PROCESSOR WAS TRIED. THE PT WAS TESTED ON (B)(6), 2010: NO FUNCTIONAL GAIN EVEN WITH AUDIO PROCESSOR SET AT MAX GAIN. THE RTF MEASUREMENT SHOWED NO RESPONSE AT ALL. THE PT HAS POOR DISCRIMINATION ON THE REPORTED SIDE AND THE AUDIOGRAM SHOWS SEVERE HEARING LOSS. BEFORE THE REPORTED PROBLEMS, THE PT WAS HEARING WITH HIS VORP BUT NOT ENOUGH DUE TO LOW LEVEL OF HIS AUDIOGRAM.

    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 57 YR