BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2823804 · Received October 30, 2012

    Report

    Report Number
    3004230826-2012-00073
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 25, 2012
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VSB WAS ASSESSED AS NONFUNCTIONAL ONE YEAR AGO BUT THE PT WANTED TO TAKE SOME TIME BEFORE DECIDING WHETHER TO BE RE-IMPLANTED OR NOT. THE PT WAS EXPLANTED ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention