BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDE

    MDR report key: 4029690 · Received August 1, 2014

    Report

    Report Number
    3004230826-2014-00072
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 25, 2014
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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 DURING THE FIRST FITTING, THE PATIENT DID NOT PERCEIVE ENOUGH LOUDNESS PRODUCED BY THE IMPLANT. HOWEVER, IN SITU TESTING WERE INDICATIVE OF A FUNCTIONAL DEVICE. THE CLINIC DECIDED TO CARRY OUT A SECOND LOOK SURGERY TO IMPROVE THE PLACEMENT OF THE FLOATING MASS TRANSDUCER (FMT) TO THE ROUND WINDOW. DURING THIS PROCEDURE, WHICH TOOK PLACE ON (B)(6) 2014, THE SURGEON REPORTEDLY REALIZED AIR OR LIQUID BUBBLES IN THE CONDUCTOR LINK, AND DECIDED TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451704 VIBRANT SOUNDBRIDE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention