BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2599027 · Received May 29, 2012

    Report

    Report Number
    3004230826-2012-00026
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    April 24, 2012
    Report Date
    May 23, 2012
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MCM
    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 HAS BEEN RETURNED TO (B)(4) WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT. NOTE: THIS DEVICE WAS MFG BY SYMPHONIX DEVICES INC. VIBRANT (B)(4) TOOK OVER THE SYMPHONIX ASSETS. AS SUCH VIBRANT (B)(4) FEELS RESPONSIBLE TO F/U ON PRODUCT PROBLEMS WITH SYMPHONIX PRODUCED DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESULTS WITH A CONVENTIONAL HEARING AID WERE BETTER THAN THOSE WITH THE VIBRANT SOUNDBRIDGE. THEREFORE, THE PT WAS EXPLANTED ON (B)(6) 2012. ACCORDING TO THE DEVICE EXPLANTATION REPORT, THE PT WAS REIMPLANTED WITH A COCHLEAR IMPLANT DUE TO PROGRESSIVE HEARING LOSS, WHICH LEAD TO INTERMITTENT BENEFIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention