BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 3042072 · Received April 3, 2013

    Report

    Report Number
    3004230826-2013-00033
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 28, 2013
    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 MFR FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S HEARING THRESHOLDS HAVE DETERIORATED. HE WAS NOT ANYMORE WITHIN THE INDICATION CRITERIA FOR THE VIBRANT SOUNDBRIDGE AND HAD NO BENEFIT FROM THE IMPLANT ANYMORE. THE PT WAS RE-IMPLANTED WITH COCHLEAR IMPLANT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136938 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention