BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1160493 · Received September 16, 2008

    Report

    Report Number
    3004230826-2008-00023
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 5, 2008
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED WITH A VIBRANT SOUNDBRIDGE IN 2008, DUE TO OTOSCLEROSIS. DURING SURGERY, WHILE DRILLING THE ROUND WINDOW NICHE, A FISTULA WAS OPENED WHICH RESULTED IN A TOTAL HEARING LOSS OF THE PT. AFTER A FEW DAYS AN AUDIOMETRIC EVALUATION WAS CARRIED OUT, WHICH CONFIRMED THAT THE PT RECEIVED NO BENEFIT WITH THE VIBRANT SOUNDBRIDGE, EVENT THOUGH THE DEVICE WAS FULLY FUNCTIONAL. THE SURGEON DECIDED TO EXPLANT THE VIBRANT SOUNDBRIDGE AND RE-IMPLANT THE PT WITH A COCHLEAR IMPLANT.

    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 31 YR Required Intervention