BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1082333 · Received July 29, 2008

    Report

    Report Number
    3004230826-2008-00014
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 21, 2008
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 MANUFACTURER 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 IS A BILATERAL VSB RECIPIENT. THE SOUND ON THE RIGHT HAND SIDE CUTS OFF AND ON WITH MOVEMENT OF HIS JAW (TALKING, CHEWING) OR WHEN HE WINKS HIS RIGHT EYE. THE CLINIC HAS SWITCHED THE AP TO THE LEFT SIDE AND IT WORKS FINE. IF PRESSURE IS PUT ON THE IMPLANTED CABLE, THE PROBLEM IS RESOLVED. IT IS BELIEVED THAT THE PROBLEM IS DUE TO THE LINKING WITH THE FMT AND THE INCUS. SURGERY IS TO BE CARRIED OUT TO CHECK ON THE PLACEMENT AND RE-POSITION AS NECESSARY.

    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