BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 3030277 · Received March 28, 2013

    Report

    Report Number
    3004230826-2013-00015
    Event Type
    Injury
    Date Received
    March 28, 2013
    Report Date
    March 26, 2013
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN DISPOSED OF BY THE CLINIC. IT WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT HAVE BENEFIT FROM THE VIBRANT SOUNDBRIDGE ANYMORE. THE PATIENT WAS EXPLANTED OF THE DEVICE ON (B)(6) 2012 FOR MEDICAL REASONS. THE EXPLANTED DEVICE HAS BEEN DISPOSED OF AND THEREFORE WILL NOT BE MADE AVAILABLE TO THE MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128647 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention