BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2023218 · Received March 15, 2011

    Report

    Report Number
    3004230826-2011-00017
    Event Type
    Injury
    Date Received
    March 15, 2011
    Report Date
    March 14, 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 SHOULD BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF THE VIBRANT SOUNDBRIDGE, THE PT WAS DEAF ON THIS SIDE. ON THE CONTRALATERAL SIDE, SHE STILL HEARS NORMALLY AS BEFORE. THE PT WAS EXPLANTED AND REIMPLANTED WITH A COCHLEAR IMPLANT. CURRENTLY, NO FURTHER INFO IS AVAILABLE.

    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 27 YR Required Intervention