BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1140167 · Received September 2, 2008

    Report

    Report Number
    3004230826-2008-00020
    Event Type
    Injury
    Date Received
    September 2, 2008
    Date of Event
    June 5, 2008
    Report Date
    August 14, 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 HAS BEEN RETURNED TO MFR WHERE IT WILL BE EVALUATED. 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 EXPLANTED AND RE-IMPLANTED DURING A REVISION SURGERY IN 2008. NO FURTHER INFO IS AVAILABLE AT THE MOMENT ABOUT THE REASONS FOR RE-IMPLANTATION.

    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 66 YR Required Intervention