BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 4101699 · Received September 15, 2014

    Report

    Report Number
    3004230826-2014-00079
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 26, 2014
    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 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 PATIENT EXPERIENCED FLUCTUATIONS IN HEARING, ESPECIALLY WHEN APPLYING PRESSURE IN THE AREA CLOSE TO THE IMPLANT. IN SITU TESTING WAS INDICATIVE OF A FUNCTIONAL DEVICE. RE-IMPLANTATION WITH A COCHLEAR IMPLANT WAS PERFORMED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570002 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention