BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2150460 · Received June 7, 2011

    Report

    Report Number
    3004230826-2011-00035
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 1, 2011
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT ORIGINALLY HAD EXCELLENT SPEECH PERCEPTION AFTER ACTIVATION. ON (B)(6), THE PT CONTACTED HIS AUDIOLOGIST REPORTING THAT HIS AMADE AUDIO PROCESSOR HAD SPONTANEOUSLY STOPPED WORKING. THE PT HAD ALREADY TRIED A REPLACEMENT PROCESSOR, BUT THIS DID NOT ALLOW THE RESUMPTION OF SOUND. DURING THE DEVICE TESTING THE RESULTS INDICATED A POSSIBLE FLOATING MASS TRANSDUCER-INCUS COUPLING PROBLEM. REVISION SURGERY IS EXPECTED TO TAKE PLACE DURING (B)(6) 2011 TO INVESTIGATE THE POSSIBLE COUPLING ISSUE.

    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