BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2170114 · Received June 21, 2011

    Report

    Report Number
    3004230826-2011-00037
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WITH CONGENITAL ATRESIA STATED NO SIGNIFICANT IMPROVEMENT IN HEARING AFTER THE DEVICE WAS ACTIVATED 6 WEEKS POST IMPLANTATION OF THE VIBRANT SOUNDBRIDGE. PROBLEMS OF THE AUDIO PROCESSOR HAVE BEEN EXCLUDED. LATER POST-OP ABR TEST REVEALED SEVERE TO PROFOUND SENSONEURAL HEARING LOSS CONTRARY TO BASICALLY NORMAL BONE CONDUCTIVE THRESHOLD CONFIRMED BY PRE-OP ABR TEST. THERE IS NO ACCIDENT OR TRAUMA KNOWN. IT IS PLANNED TO EXPLANT THE VIBRANT SOUNDBRIDGE AND REIMPLANT THE PT WITH A CI.

    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 4 YR