BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2001010 · Received February 18, 2011

    Report

    Report Number
    3004230826-2011-00009
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 15, 2011
    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 UNTIL APPROX. 3 MONTHS AGO THE PT HAD VERY GOOD BENEFIT WITH HIS VIBRANT SOUNDBRIDGE. THEN, THOSE APPROX. 3 MONTHS AGO, IT HAPPENED THAT THE AUDIO PROCESSOR DROPPED DOWN AND BROKE INTO PIECES, SO THAT THE PT COULD NOT USE IT ANY LONGER. NOT UNTIL (B)(6), 2011 THE PT KEPT A FITTING APPOINTMENT TO GET A NEW AUDIO PROCESSOR. AT THAT SESSION IT WAS DETECTED THAT HE DIDN'T HAVE ANY BENEFIT FROM THE VIBRANT SOUNDBRIDGE. TWO AUDIO PROCESSORS WERE TRIED, BUT WITHOUT SUCCESS. THE AUDIOLOGICAL EXAMINATION SHOWED THAT THE HEARING THRESHOLDS WERE STABLE AND UNCHANGED. NO RTF SIGNAL WAS MEASUREABLE WHILE TESTING ON (B)(6), 2011. THE PT WAS REIMPLANTED ON (B)(6), 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention