BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2013835 · Received February 4, 2011

    Report

    Report Number
    3004230826-2011-00003
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 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
    CA
    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 HAD NO SOUND PERCEPTION WHILST USING THE AUDIO PROCESSOR AT MAXIMUM GAIN SETTINGS. VIBROGRAM SHOWED THRESHOLDS MORE THAN 25 DB BELOW THE MEASURED BONE CONDUCTION THRESHOLDS. A CT SCAN TO ASSESS POSITION IS TO TAKE PLACE WITH SURGERY REVISION SCHEDULED FOR MARCH 8TH UNDER GENERAL ANESTHETIC TO CHECK PLACEMENT OF FMT.

    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 44 YR