BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 5498428 · Received February 22, 2005

    Report

    Report Number
    9710014-2005-00333
    Event Type
    Injury
    Date Received
    February 22, 2005
    Date of Event
    January 1, 2004
    Report Date
    February 22, 2005
    Manufacturer
    SYMPHONIX, INC. C/O VIBRANT MED-EL, HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO (B)(4) WHERE IT WILL BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THETRE WAS A NO OUTPUT CONDITION ON THE ACTIVATION (FIRST FITTING) OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MPV SYMPHONIX, INC. C/O VIBRANT MED-EL, HEARING TECHNOLOGY GMBH VORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention