BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1930667 · Received December 13, 2010

    Report

    Report Number
    3004230826-2010-00051
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 7, 2010
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS WORKING. THE PT SUFFERED FROM BILATERAL SENSORINEURAL HEARING LOSS AND HER HEARING THRESHOLD WAS NOT INSIDE THE APPROVAL CRITERIA FOR A VIBRANT SOUNDBRIDGE. SHE WENT TO THE CLINIC FOR FITTING MANY TIMES AFTER IMPLANTATION BECAUSE SHE WAS NOT SATISFIED. THE PT WAS RE-IMPLANTED ON (B)(6), 2010 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 72 YR Required Intervention