BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1505028 · Received September 14, 2009

    Report

    Report Number
    3004230826-2009-00042
    Event Type
    Malfunction
    Date Received
    September 14, 2009
    Date of Event
    September 1, 2002
    Report Date
    September 10, 2009
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT. THIS DEVICE HAS BEEN MANUFACTURED BY SYMPHONIX CORPORATION. VIBRANT MED-EL TOOK OVER THE ASSETS FROM SYMPHONIX CORP IN 2003.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT REPORTED NO OUTPUT FROM SYSTEM AND REPORTED NO TRAUMA OR OBVIOUS CAUSE. AP CHECKED OUT AS FUNCTIONING AND SYMPHONIX AUDIOLOGIST CAME TO CONFIRM INTERNAL DEVICE FAILURE. PT WAS TO BE RE-IMPLANTED AT THAT TIME BUT PERSONAL ISSUES PREVENTED THIS FROM HAPPENING THEN. DEVICE CAN BE VISUALIZED THROUGH TYMPANIC MEMBRANE AND APPEARS IN NORMAL POSITION. THE PT NOW HAS AN APPOINTMENT SCHEDULED FOR RE-IMPLANTATION SURGERY ON (B) (6) 2009.

    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