BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 4029683 · Received August 1, 2014

    Report

    Report Number
    3004230826-2014-00073
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 25, 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 CLAIMED TO HAVE FALLEN AGAINST A CUPBOARD SEVERAL WEEKS OR MONTHS BEFORE THE INCIDENT WAS REPORTED. AFTERWARDS, A DECREASE IN HEARING PERFORMANCE WAS PERCEIVED. THE PATIENT'S AUDIOLOGIST WAS UNSURE IF THIS ACCIDENT WAS THE REASON FOR THE DECREASE IN HEARING PERFORMANCE, AS THE AUDIOMETRY GAVE NO INDICATION. HOWEVER, PROGRESSIVE HEARING LOSS WAS ALSO OBSERVED LEAVING THE PATIENT OUTSIDE OF THE INDICATION CRITERIA FOR THE VIBRANT SOUNDBRIDGE. THE PATIENT WAS EXPLANTED OF THE VIBRANT SOUNDBRIDGE, AND RE-IMPLANTED WITH A COCHLEAR IMPLANT ON (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451687 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention