BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2093394 · Received April 19, 2011

    Report

    Report Number
    3004230826-2011-00023
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    April 6, 2011
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S EAR HAS AN INFECTION. THE INFECTION HAS BEEN TREATED WITH ANTIBIOTICS AND OTHER MEDICATION BUT WITHOUT SUCCESS. THE PHYSICIANS THINK THAT POSSIBLY HIS EAR IS REJECTING THE IMPLANT. THE PT CAN HEAR A LITTLE WITH THE IMPLANT BUT NOT ENOUGH THAT HE CAN UNDERSTAND SPEECH NEAR HIM.

    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 58 YR