BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 3122208 · Received May 17, 2013

    Report

    Report Number
    3004230826-2013-00048
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFO WAS RECEIVED THAT THE PT HAD BEEN EXPLANTED OF THE IMPLANT. NO MENTION WAS MADE OF WHEN THIS HAD OCCURRED OR THE REASONS LEADING TO THE EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218775 VIBRANT SOUNDBRIDGE VORP MPV MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH 31608

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention