BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2850695 · Received November 20, 2012

    Report

    Report Number
    3004230826-2012-00082
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    November 16, 2012
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER 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 THE PT DID NOT HAVE SUFFICIENT HEARING PERFORMANCE WITH HER VIBRANT SOUNDBRIDGE, DUE TO HER HEARING THRESHOLDS BEING PRESUMPTIVELY AT THE BORDER BETWEEN VIBRANT SOUNDBRIDGE AND COCHLEAR IMPLANT INDICATION CRITERIA. THE PT WAS RE-IMPLANTED WITH A COCHLEAR IMPLANT 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 26 YR Required Intervention