BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 7288313 · Received February 22, 2018

    Report

    Report Number
    9710014-2018-00133
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    February 21, 2018
    Report Date
    June 25, 2018
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE RECEIVED INFORMATION, A DAMAGE TO THE CONDUCTIVE LINK OR TO THE DEVICE APPEARS LIKELY, AS INDICATED BY IN-SITU TESTING. HOWEVER TO DETERMINE AND CONFIRM AN EXACT ROOT CAUSE OF FAILURE A DEVICE INVESTIGATION TO THE EXPLANTED DEVICE WOULD BE NECESSARY. THE DEVICE HAS BEEN EXPLANTED, BUT REPORTEDLY THE EXPLANT COULD NOT BE LOCATED AND WILL NOT BE RETURNED FOR INVESTIGATION. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO 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

    ON (B)(6).2018 THE USER VISITED THE MED-EL (B)(6) OFFICE. SHE REPORTED THAT SHE HAS NOT BEEN ABLE TO HEAR ANY SOUND WITH THE DEVICE SINCE (B)(6).2018. THIS LOSS OF SOUND WAS SUDDEN. THE DEVICE HAS BEEN EXPLANTED; HOWEVER THE EXPLANT COULD NOT BE LOCATED AND WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE USER VISITED THE MED-EL (B)(4) OFFICE. SHE REPORTED THAT SHE HAS NOT BEEN ABLE TO HEAR ANY SOUND WITH THE DEVICE SINCE (B)(6) 2018. THE USER HAS AN APPOINTMENT ON (B)(6) 2018, RECOMMENDATION FROM VIBRANT CLINICAL SUPPORT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133388 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MPV MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH VORP

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention