BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2043461 · Received February 25, 2011

    Report

    Report Number
    3004230826-2011-00012
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 22, 2011
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SOUND FROM THE VIBRANT SOUNDBRIDGE IS NOT LOUD ENOUGH AND THE PARENTS OF THE PT REPORTED THAT SHE CANNOT DO THINGS THAT SHE COULD DO AFTER THE DEVICE WAS FITTED, SUCH AS HEAR IN THE CAR. THEY STATE THAT SHE IS BACK TO LIP-READING. BKB SENTENCE SCORES DROPPED FROM PREVIOUS 98% TO 0% CORRECT UNDERSTANDING. MASKED AIDED THRESHOLDS DO NOT SHOW ANY BENEFIT FROM THE DEVICE. BONE CONDITION THRESHOLDS REMAIN UNCHANGED. VIBROGRAM THRESHOLDS HAVEN'T BEEN DETECTABLE.

    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