BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1994295 · Received January 14, 2011

    Report

    Report Number
    3004230826-2011-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    January 10, 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 EVALUATION. 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 PATIENT IS NO LONGER ABLE TO HEAR WITH HIS DEVICE. HE REALIZED IN (B)(6) 2010 THAT HIS AUDIO PROCESSOR WAS NOT WORKING. DURING AN APPOINTMENT WITH HIS AUDIOLOGIST, IT WAS CONFIRMED THAT THE AUDIO PROCESSOR WAS FUNCTIONAL. A VIBROGRAM WAS CARRIED OUT WITHOUT OBTAINING ANY THRESHOLD. THE AUDIOLOGICAL THRESHOLDS DID NOT SHOW ANY CHANGE IN HEARING, THE MIXED HEARING LOSS IS STABLE.

    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 58 YR