BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2080408 · Received April 22, 2011

    Report

    Report Number
    3004230826-2011-00025
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 20, 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 MFR FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT STATED, THAT SHE IS NO LONGER ABLE TO HEAR WITH HER VIBRANT SOUNDBRIDGE SINCE APPROX 2 MONTHS. ACCORDING TO THE ENT-DOCTOR, SHE SEEMS TO HAVE CLEANED HER EAR CANAL BY HERSELF VERY OFTEN - PROBABLY WITH Q-TIPS. THE CABLE OF THE VIBRANT SOUNDBRIDGE CAME OUT OF THE EAR CANAL BY THE TIME, OR WAS VISIBLE DIRECTLY UNDER THE SKIN. AFTER SHE CLEANED HER EAR CANAL HERSELF ONCE MORE, SHE WAS NO LONGER ABLE TO HEAR WITH HER VIBRANT SOUNDBRIDGE. DURING A SURGERY CARRIED OUT ON (B)(6), 2011, IT WAS TRIED TO REPOSITION THE FMT, BUT AS THIS WAS NOT POSSIBLE, THE PT WAS REIMPLANTED.

    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 53 YR Required Intervention