BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2171436 · Received December 2, 2007

    Report

    Report Number
    3004230826-2007-00002
    Event Type
    Malfunction
    Date Received
    December 2, 2007
    Date of Event
    January 1, 2006
    Report Date
    February 8, 2007
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVER THE PAST TWO MONTHS, THE PT HAS COMPLAINED ABOUT INTERMITTENCIES WHICH HAVE APPEARED MORE AND MORE FREQUENTLY. ANOTHER AUDIO PROCESSOR WAS TRIED AS IT WAS BELIEVED TO BE THE SOURCE OF THE INTERMITTENCIES, BUT THE NEW AP DID NOT IMPROVE THE SITUATION AND THE PT REPORTED NOT HEARING ANYMORE WITH HIS AP. ON (B)(6), 2007 THE PT WAS SEEN BY A VIBRANT MED-EL MEMBER OF STAFF. ANOTHER AP WAS TRIED AND AN RTF INTEGRITY TEST WAS CARRIED OUT BUT THERE WAS NO MEASURABLE OUTPUT AND NO AMPLIFICATION WAS PERCEIVED BY THE PT.

    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