BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 3013040 · Received March 15, 2013

    Report

    Report Number
    3004230826-2013-00025
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    March 8, 2013
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 FEELS PAIN AT THE AREA OF HER FACE OR HEAD ON THE IMPLANTED SIDE. SHE ALSO FEELS A BURNING PAIN ON THE SURFACE. THE PAIN STARTED IN (B)(6) 2012, AFTER THE SURGICAL WOUND HAD HEALED. IT IS CONTINUOUSLY PRESENT, WITH OR WITHOUT THE AUDIO PROCESSOR BEING SWITCHED ON, AND NOT ALWAYS OF THE SAME INTENSITY. THE PT HAS NOT BEEN USING HER AUDIO PROCESSOR FOR THE LAST 2 WEEKS. THE EXTERNAL PARTS WERE CHECKED AND FOUND TO BE FUNCTIONAL. THE PT HAS GOOD HEARING PERFORMANCE WITH HER IMPLANT. NO PRESSURE MARKS ARE VISIBLE EXTERNALLY. AN ALLERGY TEST IS TO BE CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110454 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR