BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 3011121 · Received March 15, 2013

    Report

    Report Number
    3004230826-2013-00022
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    August 8, 2012
    Report Date
    March 8, 2013
    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 FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY BECAUSE OF A POLYP IN THE LEFT EAR CANAL. A RECURRENT CHOLESTEATOMA WAS FOUND INTRAOPERATIVELY. THEREFORE THE VIBRANT SOUNDBRIDGE AND THE COUPLER WERE REMOVED. NO FURTHER DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110706 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention