BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 3023040 · Received March 21, 2013

    Report

    Report Number
    3004230826-2013-00029
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 19, 2013
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON THE LEFT SIDE ON (B)(6) 2008. SHE SUFFERED FROM SNHL. THE PATIENT WAS NOT SATISFIED OF THE PERFORMANCE DURING THE LAST YEAR DUE TO AN DECREASING OF THE HEARING THRESHOLDS. EXPLANTATION OF THE DEVICE WAS SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117747 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR