BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 676112 · Received February 8, 2006

    Report

    Report Number
    3004230826-2006-00002
    Event Type
    Malfunction
    Date Received
    February 8, 2006
    Date of Event
    November 1, 2005
    Report Date
    January 30, 2006
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MAH
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A NO OUTPUT CONDITION. THE PT WAS SEEN IN DECEMBER 2005 BY A VIBRANT MED-EL STAFF MEMBER AT THE ACOUSTICIAN'S OFFICE. THE PT REPORTED THAT ONE DAY SHE REALIZED SHE COULD NOT HERA ANYTHING WITH HER AUDIO PROCESSOR ON. SHE WNET TO HER ACOUSTICIAN TO HAVE HER AUDIO PROCESSOR CHECKED AND THE ACOUSTICIAN FOUND THE AUDIO PROCESSOR TO BE FUNCTIONING PROPERLY. TESTING WAS CARRIED OUT IN DECEMBER 2005 AND FUNCTIONAL GAIN SHOWED NO SIGNIFICANT DIFFERENCE BETWEEN THE UNAIDED AND AIDED THRESHOLDS FOR WARBLE TONES IN SOUNDFIELD. THE PT WAS SEEN AGAIN AT THE HOSPITAL IN JANUARY 2006 AND A DECISION WAS MADE FOR THE PT TO BE RE-IMPLANTED. NO DATE HAS BEEN SET FOR THE SURGERY YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MAH VIBRANT MED-EL HEARING TECHNOLOGY GMBH VORP *

    Patients

    Seq Age Sex Outcome Treatment
    1 *