BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1990654 · Received February 8, 2011

    Report

    Report Number
    3004230826-2011-00004
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 3, 2011
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO INNSBRUCK WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VORP'S BENEFIT FOR THE PT DECREASED BY THE TIME, UNTIL SHE NO LONGER HAD AN ADEQUATE BENEFIT. THE AUDIOGRAM SHOWS A DECREASE OF THE BONE CONDUCTION THRESHOLDS BELOW THE INDICATION RANGE FOR A VIBRANT SOUNDBRIDGE. THE PT SUFFERS FROM COCHLEAR OTOSCLEROSIS. SHE EXPLANTED ON (B)(6), 2011. BEFORE THE SURGERY, THE DEVICE WAS TESTED AND PROVED TO BE INTACT.

    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 48 YR Required Intervention