BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2051126 · Received April 5, 2011

    Report

    Report Number
    3004230826-2011-00022
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 4, 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 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 HAS ATRESIA. HE WAS NO LONGER ABLE TO HEAR WITH HIS DEVICE. THE EXTERNAL PARTS WERE CHECKED AND FUNCTIONAL. HE HAD EXCELLENT HEARING PERFORMANCE WITH HIS DEVICE AFTER IMPLANTATION. NO ACCIDENT WAS REPORTED. THE PATIENT WAS RUNNING WITHOUT THE AUDIO PROCESSOR. AFTER HE ATTACHED THE AUDIO PROCESSOR, HE HAD NO HEARING SENSATION ANYMORE. A REVISION SURGERY WAS PLANNED FOR (B)(6), 2011. DURING THE REVISION SURGERY, THE IMPLANT WAS REMOVED TO BE EXAMINED, WITH THE FLOATING MASS TRANSDUCER DIRECTLY PLACED TO THE MEMBRANE OF THE STETHOSCOPE: NO SOUNDS COULD BE HEARD. THE PATIENT WAS RE-IMPLANTED DURING THIS SURGERY ON (B)(6), 2011.

    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 UNK Required Intervention