BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 2230695 · Received August 17, 2011

    Report

    Report Number
    3004230826-2011-00051
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 10, 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 MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT. THIS DEVICE HAS BEEN MFG BY SYMPHONIX CORP. VIBRANT MED-EL TOOK OVER THE ASSETS FROM (B)(4) IN 2003.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAPACITY OF THE INNER EAR DETERIORATED DURING THE LAST YEARS, SO THAT IT WAS FINALLY OUTSIDE THE INDICATION CRITERIA FOR A VIBRANT SOUNDBRIDGE AND THE PT HAD ONLY VERY LOW HEARING SENSATION WITH HIS IMPLANT. ADDITIONALLY, HEARING SENSATION HAD BEEN FLUCTUATING FOR SOME TIME. AN ACCIDENT OR TRAUMA IS NOT KNOWN. THE EXTERNAL PARTS WERE CHECKED. THE PT WAS EXPLANTED ON (B)(6) 2011 AND REIMPLANTED WITH A COCHLEAR IMPLANT.

    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 81 YR Required Intervention