BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2361592 · Received November 25, 2011

    Report

    Report Number
    3004230826-2011-00076
    Event Type
    Injury
    Date Received
    November 25, 2011
    Report Date
    November 23, 2011
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT. NOTE: THIS DEVICE WAS MANUFACTURED BY SYMPHONIX INC. VIBRANT MED-EL TOOK OVER THE SYMPHONIX ASSETS. AS SUCH VIBRANT MED-EL FEELS RESPONSIBLE TO FOLLOW-UP ON PRODUCT PROBLEMS WITH SYMPHONIX PRODUCED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED IN 2001. SHE WAS A NON-USER FOR THE LAST COUPLE OF YEARS. THE PATIENT WAS WILLING TO BE EXPLANTED AND TRY A HEARING AID. THE VORP WAS FUNCTIONAL. THE PATIENT WAS EXPLANTED ON (B)(6), 2011.

    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 Required Intervention