BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 4168490 · Received July 16, 2014

    Report

    Report Number
    3004230826-2014-00065
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 8, 2014
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 IN SITU TESTING SHOWED THAT THE DEVICE HAS MALFUNCTIONED AND THAT THE PT'S HEARING DETERIORATED TO AN EXTENT, WHICH LEFT THE PT OUTSIDE OF DEVICE INDICATION CRITERIA. THEREFORE, THE CLINIC IS CONSIDERING RE-IMPLANTATION WITH A COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416426 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH 32401V

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR