BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2230690 · Received August 17, 2011

    Report

    Report Number
    3004230826-2011-00050
    Event Type
    Injury
    Date Received
    August 17, 2011
    Report Date
    August 5, 2011
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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'S HEARING SENSATION GOT WORSE BY THE TIME UNTIL SHE HAD NO BENEFIT AT ALL. A REVISION SURGERY WAS CARRIED OUT TO REPOSITION THE FMT IF NECESSARY. DURING THIS OPERATION, THE SURGEON ASSUMED HAVING SEEN A WIRE BREAKAGE. THIS LED HIM TO EXPLANT THE VIBRANT SOUNDBRIDGE AND REIMPLANT THE PATIENT WITH A NEW ONE. AFTER EXPLANTATION THE SURGEON COULD NOT CLEARLY IDENTIFY UNDER THE MICROSCOPE, IF THIS WAS A WIRE BREAKAGE.

    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 60 YR Required Intervention